BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERICARDIOCENTESIS KIT

    MDR report key: 3190493 · Received June 21, 2013

    Report

    Report Number
    1125782-2013-00012
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 24, 2013
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Product Code
    GBX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVAL: ONE USED SUSPECT DEVICE WAS RETURNED FOR EVAL. THE EVAL IS IN PROCESS. THE EXPIRATION DATES AND DEVICE MANUFACTURE DATES FOR THE TWO LOTS REPORTED BY THE USER ARE PROVIDED BELOW: T423047, EXPIRATION DATE: 05/31/2015, DEVICE MANUFACTURE DATE: 12/01/2012. T433195, EXPIRATION DATE: 07/31/2015, DEVICE MANUFACTURE DATE: 02/01/2013. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVAL HAS BEEN COMPLETED. EVAL CODES: RESULTS: RESULTS PENDING COMPLETION OF EVAL. CONCLUSIONS: CONCLUSION NOT YET AVAILABLE- EVAL IN PROGRESS.

    Description of Event or Problem · 1

    THE USER INITIALLY REPORTED THAT THE DRAINAGE CATHETER RUPTURED APPROX. 3 CM FROM THE HUB AFTER REMOVAL FROM THE PATIENT. WHEN THE USER WAS CONTACTED FOR ADD'L INFO, THEY REQUESTED THAT THE "AFTER REMOVAL" STATEMENT BE CHANGED TO "UNK." THE USER WAS UNABLE TO PROVIDE ANY ADD'L INFO IN REGARDS TO THE EVENT. TWO POSSIBLE LOT NUMBERS WERE PROVIDED BY THE USER FOR THE DEVICE, T423047 AND T433195. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO HARM OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283817 PERICARDIOCENTESIS KIT CATHETER, IRRIGATION GBX MERIT MEDICAL SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1