BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT FILL NEEDLE

    MDR report key: 8492813 · Received April 8, 2019

    Report

    Report Number
    1911916-2019-00360
    Event Type
    Malfunction
    Date Received
    April 8, 2019
    Date of Event
    March 15, 2019
    Report Date
    April 18, 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
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TEN (10) UNUSED SAMPLES WERE RECEIVED IN THE SEALED BLISTER PACKAGING BY OUR QUALITY TEAM FOR INVESTIGATION. 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. THEREFORE, THE CONDITIONS REPORTED CANNOT BE VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THESE BATCHES. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THE REPORTED CONDITIONS CANNOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL NO. 305180 BATCH NO. 8173882 IT WAS REPORTED THAT DURING USE OF THE BD¿ BLUNT FILL NEEDLE THERE WERE ISSUES WITH CORING, INSERTION DIFFICULTY, LEAKAGE, AND CANNOT DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 305180 BATCH, NO. 8173882. IT WAS REPORTED THAT DURING USE OF THE BD¿ BLUNT FILL NEEDLE THERE WERE ISSUES WITH CORING, INSERTION DIFFICULTY, LEAKAGE, AND CANNOT DRAW. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 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
    283226 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