BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLEZ

    MDR report key: 9172282 · Received October 9, 2019

    Report

    Report Number
    1911916-2019-01069
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    August 28, 2019
    Report Date
    October 31, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: TEN (10) SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE RETURNED IN UNOPENED BLISTER PACKS AND WERE VISUALLY EXAMINED USING 10X MAGNIFICATION WITH NO HOLES BEING FOUND IN THE NEEDLE HUBS. THE NEEDLE ASSEMBLIES WERE THEN ATTACHED TO A SYRINGE FILLED WITH DYE AND WATER AND PUSHED INTO A STOPPER TO PLUG THE NEEDLE END. THE PLUNGER ON THE SYRINGE WAS DEPRESSED AND THE NEEDLE HUBS WERE INSPECTED FOR LEAKAGE. NONE OF THE RETURNED SAMPLES LEAKED WHEN TESTED THIS WAY. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION BD WAS NOT ABLE TO CONFIRM THE CONDITION REPORTED BY THE CUSTOMER; THEREFORE, A ROOT CAUSE CANNOT BE DETERMINED. AS A RESULT, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE PROPOSED IN THE SCOPE OF THIS COMPLAINT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    MATERIAL NO: 305109; BATCH NO: 8250590. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE ON 5 DIFFERENT OCCASIONS MEDICATION LEAKED OUT. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS GIVEN SYRINGE WITH NEED ATTACHED. UPON INJECTION THE MEDICATION LEAKED. THIS OCCURRED ON 5 DIFFERENT OCCASIONS WITH THE SAME TIPS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 1

    MATERIAL NO: 305109, BATCH NO: 8250590. IT WAS REPORTED THAT DURING USE OF THE BD PRECISIONGLIDE¿ NEEDLE ON 5 DIFFERENT OCCASIONS MEDICATION LEAKED OUT. THIS OCCURRED ON 5 SEPARATE OCCASIONS BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT WAS GIVEN SYRINGE WITH NEED ATTACHED. UPON INJECTION THE MEDICATION LEAKED. THIS OCCURRED ON 5 DIFFERENT OCCASIONS WITH THE SAME TIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964712 BD PRECISIONGLIDE¿ NEEDLEZ HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8250590 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other