BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAGEL 4.5ML

    MDR report key: 3131881 · Received May 29, 2013

    Report

    Report Number
    0002530131-2013-00003
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN ADDITIONAL CHECK DURING THE KITTING PROCESS HAS BEEN ADDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON OPENING BOX OF VITAGEL 4.5, DURING PREP FOR A PROCEDURE, THE STERILE PLASTIC SURROUNDING THE EMPTY TRANSFER SYRINGE HAD A HOLE IN IT. A VISUAL INSPECTION OF THE RETURNED PRODUCT CONFIRMED A SMALL HOLE ON THE PACKAGING BY THE LUER. THE ROOT CAUSE FOR THIS FAILURE MODE COULD NOT BE CONFIRMED HOWEVER IT IS LIKELY THAT THE EMPTY PLASMA TRANSFER SYRINGE MAY HAVE COME INTO CONTACT WITH THE VITAGEL SYRINGE. THIS COULD HAVE OCCURED DURING THE MANUFACTURER KITTING PROCESS OR DURING HANDLING AT THE SURGICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235900 VITAGEL 4.5ML VITAGEL 4.5 ML LMF STRYKER ORTHOBIOLOGICS-MALVERN A1302034

    Patients

    Seq Age Sex Outcome Treatment
    1 Other