BEUDAMED
    FDA Adverse Event Other Summary report: N

    BOSTON SCIENTIFIC / NAMIC

    MDR report key: 384870 · Received March 26, 2002

    Report

    Report Number
    1317056-2002-00009
    Event Type
    Other
    Date Received
    March 26, 2002
    Date of Event
    January 30, 2002
    Report Date
    February 27, 2002
    Manufacturer
    BOSTON SCIENTIFIC / NAMIC
    Product Code
    BYX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PER LETTER REC'D, NAMIC 48" PRESSURE MONITORING LINE WAS SOLD OEM TO MAXXIM MED. AND PUT IN A MAXXIM CUSTOM KIT. DURING A PROCEDURE, A PT WAS TRANSFERRED FROM ANGIO TO RECOVERY. UPON TRANSFERRING THE PT TO THE BED IN RECOVERY, BLEEDING WAS DETECTED. THE SOURCE OF THE BLEEDING WAS A DETACHMENT OF THE TUBING FROM THE FITTING OF THE 48" LINE. THEY THEN PULLED ANOTHER UNIT FROM THE SAME LOT AND EXPERIENCED NO DIFFICULTY WITH THAT UNIT. MAXXIM HAS FILED A MEDWATCH ON THE EVENT. THE HOSPITAL HAS DISCARDED THE USED DEVICE. MAXXIM HAS RETURNED UNUSED PIECES FROM THE 2 NAMIC LOTS USED IN THE CUSTOM KIT MADE FOR THE HOSPITAL. PER INFO REC'D FROM MAXXIM MEDICAL, THE PT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BOSTON SCIENTIFIC / NAMIC 48" ADULT PRESSURE MONITORING LINE BYX BOSTON SCIENTIFIC / NAMIC * 762398,764932

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other