BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLES - 32G 4MM

    MDR report key: 11838405 · Received May 17, 2021

    Report

    Report Number
    9616656-2021-00544
    Event Type
    Malfunction
    Date Received
    May 17, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 5 BD ULTRA FINE¿ PEN NEEDLES 4MM X 32G HAD THE SEAL WHERE STERILITY IS COMPROMISED (TEAR DROP LABEL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : MATERIAL NO. 320122 BOTH BOXES; BATCH NO. 0142932 AND UNKNOWN. CONSUMER REPORTED FINDING MISSING PAPER TABS ON THE PEN NEEDLE DATE OF EVENT: (B)(6) 2021 = 4 PEN NEEDLES. SAMPLES STATUS DISCARD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 BD ULTRA FINE¿ PEN NEEDLES 4MM X 32G HAD THE SEAL WHERE STERILITY IS COMPROMISED (TEAR DROP LABEL). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BOTH BOXES; BATCH NO. 0142932 AND UNKNOWN. CONSUMER REPORTED FINDING MISSING PAPER TABS ON THE PEN NEEDLE DATE OF EVENT: (B)(6) 2021 = 4 PEN NEEDLES. SAMPLES STATUS DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    733465 BD ULTRA FINE PEN NEEDLES - 32G 4MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0142932 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1