BEUDAMED
    FDA Adverse Event Other Summary report: N

    VITAPREP PLASMA SEPRATOR 5-PACK

    MDR report key: 2771723 · Received September 27, 2012

    Report

    Report Number
    2530131-2012-00014
    Event Type
    Other
    Date Received
    September 27, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 6, 2012
    Manufacturer
    STRYKER ORTHOBIOLOGICS MALVERN
    Product Code
    LMF
    PMA / PMN Number
    P050044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE IS CURRENTLY UNDER INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PLUNGER ON THE VITAGEL TRANSFER SYRINGE WAS SUNCTIONED BACK FOLLOWING THE TRANSFER AND DISCONNECT OF THE VITAPREP. AS A RESULT A SCRUB NURSE WAS EXPOSED TO PT PLASMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VITAPREP PLASMA SEPRATOR 5-PACK IMPLANT LMF STRYKER ORTHOBIOLOGICS MALVERN NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA