Medical Product Safety Network

$447.50 / year

The Medical Product Safety Network (MedSun) is an adverse event reporting program launched by the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH).

Complexity

The Medical Product Safety Network dataset involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes and home health facilities around the United States.
MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun utilizes a secure, online system for reporting problems with the use of medical devices. MedSun plays a critical role in FDA’s postmarket surveillance efforts.

The primary goal for MedSun is to work collaboratively with the clinical community to identify, understand, and solve problems with the use of medical devices.
The Safe Medical Devices Act (SMDA) defines ‘user facilities’ as hospitals, nursing homes, and outpatient treatment and diagnostic centers. They are required to report medical device problems that result in serious illness, injury, or death. MedSun participants are also highly encouraged to voluntarily report problems with devices, such as ‘close-calls,’ potential for harm, and other safety concerns. By monitoring reports about problems and concerns before a more serious event occurs, FDA, manufacturers, and clinicians work together proactively to prevent serious injuries and death.

Date Created

2002

Last Modified

2019-06-26

Version

2019-06-26

Update Frequency

Daily

Temporal Coverage

2006-03-24 to 2019-06-26

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Medical Product Safety, Adverse Event Reporting Program, MedSun, MD Safety, MD Reporting

Other Titles

MedSun Adverse Events Reports, MD Medical Product Safety Network, Medical Devices Safety Network

NameDescriptionTypeConstraints
Device_BrandThe brand of medical devicestring-
Device_ManufacturerDevice manufacturer namestring-
Device_TypeThe type of medical devicestring-
Device_ProblemProblem associated with the devicestring-
Date_ReportThe Date reportdaterequired : 1
Event_DescriptionThe Event descriptionstring-
Device BrandDevice ManufacturerDevice TypeDevice ProblemDate ReportEvent Description
Megadyne E-Z CleanMEGADYNE MEDICAL PRODUCTS INC.ELECTROSURGICAL CUTTING COAGULATION ACCESSORIESPotential for patient harm;Potential harm to a health care provider2019-07-15Malfunction of megadyne ultra vac surgical pencil tip. At the beginning of surgical procedure surgeon noticed a sparking at the tip of smoke pencil towards the suction of the megadyne ulta vac - with a quick flare-flame which surgeon immediately stopped using. No harm to patient or surgical team.
Harmonics Ultrasonic handpieceStryker Sustainability Solutionsinstrument ultrasonic surgicalPotential for patient harm2019-07-15Harmonic was plugged in - noting error message replace handpiece. Checked machine settings for cord uses: 40 remained. Obtained second handpiece - received error message. After trying third handpiece - passed test and worked properly. Two defective devices were from same lot number. Other devices from same lot number were removed.
SigniaCovidien LPSTAPLE IMPLANTABLEPotential for patient harm2019-07-15Battery was not recognized by shell - alert stating shell was defective.
CAREFUSION 303 INC.BD Alaris Pump Infusion SetPotential for patient harm2019-07-15Kinked BD tubing set. We are finding several kinked tubing sets that are brand new out of the package.
ECHELON FLEXEthicon Endo-Surgery Inc.staple implantablePotential for patient harm2019-07-15Vascular stapler misfired. This was a possible defective cartridge or stapler device. Possible defective cartridge or stapler device. MD was required to manually oversew the pulmonary vein while it was bleeding profusely.
Endopath ETS-FLEX 45Ethicon Endo-Surgery Inc.staple implantablePotential for patient harm2019-07-15Due to faulty stapler - the staple line bleed.
StrykeFlowSTRYKER ENDOSCOPYLaparoscope general & plastic surgeryPotential for patient harm2019-07-15Device was leaking saline at battery port.
Bard® Urethral Catheterization Tray with Red Rubber CatheterC.R. Bard Inc.CATHETER UROLOGICALPotential for patient harm2019-07-15Straight cath kit with missing providone-iodine swabs. Two kits from the same lot have been identified with this same problem so far. Both were discarded and another kit was obtained. No harm to either patient. Event results in a delay while another kit is obtained.
AESCULAPAesculap AGELECTROSURGICAL CUTTING COAGULATION ACCESSORIESPotential for patient harm2019-07-15SURGEON NOTED A PIECE OF WHITE PLASTIC ON THE OMENTUM WAS FOUND - WHICH LOOKS LIKE THE PROTECTIVE COATING OF THE JAWS OF CAIMAN DEVICE WHICH WAS CHIPPED. CAIMAN WAS INSPECTED AND ALL PARTS ACCOUNTED WHICH WAS COMPLETE INCLUDING THE MISSING CHIPPED PART.
Alaris SmartSiteCAREFUSION 303 INC.Set administration intravascularPotential for patient harm2019-07-15Patient was in CT scan - to receive IV contrast through her portacath. IV was connected to IV infusion pump at 20ml/hr. IV tubing clamped at the roller clamp mid tubing and distal port clamp. IV contrast infusing and tubing broke at top of IV infusion pump at connector above soft tubing - leaking normal saline.