BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8436252 · Received March 20, 2019

    Report

    Report Number
    1911916-2019-00288
    Event Type
    Malfunction
    Date Received
    March 20, 2019
    Date of Event
    March 1, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: DURING DHR REVIEW THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #8173882 DURING THIS PRODUCTION RUN. 10 SAMPLES WERE RECEIVED. THEY CAME IN THE SEALED PACKAGING BLISTER. FUNCTIONAL TEST WAS PERFORMED BY DRAWING SALINE SOLUTION, NO ISSUES WERE EXPERIENCED, NO LEAKAGE WAS OBSERVED. VISUAL INSPECTION UNDER THE MICROSCOPE WAS PERFORMED FINDING NO DAMAGE, ETCH WAS GOOD. NO DEFECTIVE GRIND, NO HOOKS WERE OBSERVED. THE COMPLAINT COULD NOT BE CONFIRMED AND A ROOT CAUSE NOT DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD¿ BLUNT FILL NEEDLE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO. 305180 BATCH NO. 8173882. IT WAS REPORTED THERE WAS CORING, INSERTION DIFFICULTY, LEAKAGE, AND CANNOT DRAW. BEVEL AND THICKNESS OF NEEDLE IS LARGER AND FLATTER THAN NORMAL. REQUIRES A LOT OF FORCE TO PUNCTURE IV BAG PARTS AND VIAL STOPPERS(CAUSING CORING AND PUNCTURING OF IV BAGS(LEAKING), NEEDLE SQUEAKS WHEN ENTERING VIAL STOPPER CANT MANIPULATE NEEDLE ONCE IN VIAL - UNABLE TO MOVE NEEDLE ONCE IN VIAL/DIFFICULTY ADDING AIR AND DRAWING IN MEDICATION, WHICH REQUIRES MULTIPLE PUNCTURES. THIS LOT OF NEEDLES IS A SAFETY CONCERN AS IT CAN AFFECT THE FINAL PRODUCT AND CAUSES WASTAGE OF DRUG. NORMALLY, WE DO NOT HAVE ISSUES WITH THIS PRODUCT BUT THIS LOT APPEARS TO BE FAULTY."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ BLUNT FILL NEEDLE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. VERBATIM: "MATERIAL NO. 305180 BATCH NO. 8173882. IT WAS REPORTED THERE WAS CORING, INSERTION DIFFICULTY, LEAKAGE, AND CANNOT DRAW. BEVEL AND THICKNESS OF NEEDLE IS LARGER AND FLATTER THAN NORMAL. REQUIRES A LOT OF FORCE TO PUNCTURE IV BAG PARTS AND VIAL STOPPERS(CAUSING CORING AND PUNCTURING OF IV BAGS(LEAKING), NEEDLE SQUEAKS WHEN ENTERING VIAL STOPPER CANT MANIPULATE NEEDLE ONCE IN VIAL - UNABLE TO MOVE NEEDLE ONCE IN VIAL/DIFFICULTY ADDING AIR AND DRAWING IN MEDICATION, WHICH REQUIRES MULTIPLE PUNCTURES. THIS LOT OF NEEDLES IS A SAFETY CONCERN AS IT CAN AFFECT THE FINAL PRODUCT AND CAUSES WASTAGE OF DRUG. NORMALLY, WE DO NOT HAVE ISSUES WITH THIS PRODUCT BUT THIS LOT APPEARS TO BE FAULTY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228594 BD¿ BLUNT FILL NEEDLE MANUAL SURGICAL INSTRUMENT FOR GENERAL USE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 8173882 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 Other