BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDIATRIC BONE MARROW NEEDLE

    MDR report key: 2102053 · Received April 13, 2011

    Report

    Report Number
    1036710-2011-00004
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES
    Product Code
    KNW
    PMA / PMN Number
    K980196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FROM THE DISTRIBUTOR FOR REVIEW. THE HOLE IN THE PACKAGING WAS CONFIRMED IN THE RETURNED DEVICE. THE HOLE IS AT THE TOP OF THE POUCH AND APPEARS TO BE CAUSED FROM THE HUB ON THE POLY SIDE OF THE POUCH. AS THIS COMPLAINT CAME FROM A DISTRIBUTOR IN (B)(6) AND WE HAVE RECEIVED NO OTHER CUSTOMER COMPLAINTS FOR THIS DEFECT, IT HAS BEEN DETERMINED BY THE MFR THAT THE ROOT CAUSE IS IMPACT DURING SHIPMENT; SPECIFICALLY, THE EXTENDED SHIPMENT TO (B)(6). THE CURRENT PREVENTATIVE ACTION FOR THIS DEFECT IS INSPECTION ON-SITE BY THE DISTRIBUTOR IN (B)(6). THE DEFECT IS READILY VISIBLE BY THE CUSTOMER. WE WILL CONTINUE TO MONITOR AND TREND TO TAKE ACTION WHEN NECESSARY.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THERE IS A HOLE IN THE CLEAR FILM OF THE POUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEDIATRIC BONE MARROW NEEDLE BONE MARROW NEEDLE KNW ANGIOTECH, MEDICAL DEVICE TECHNOLOGIES ION18015 10192509

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R