BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE¿ NANO¿ PEN NEEDLE

    MDR report key: 10045614 · Received May 11, 2020

    Report

    Report Number
    9616656-2020-00407
    Event Type
    Malfunction
    Date Received
    May 11, 2020
    Date of Event
    April 29, 2020
    Report Date
    May 1, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY - THE CUSTOMER RETURNED PHOTOS OF A SHELF CARTON OF 4 MM, 32 G PEN NEEDLES FROM LOT # 5161378. CUSTOMER STATES THAT THE PACKS DID NOT HAVE MANUFACTURING/EXPIRY DATE NOR THE UDI (UNIQUE DEVICE IDENTIFIER). THIS BATCH WAS CREATED IN 2015 AND UDI WAS NOT IMPLEMENTED UNTIL (B)(6) 2016. THERE WAS NO EXPIRATION DATE ON THE PACKAGING BECAUSE BATCH WAS CREATED IN 2015 AND EXPIRATION DATES ON PACKAGING WAS IMPLEMENTED IN (B)(6) 2017. 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 BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE THE BD ULTRA FINE¿ NANO¿ PEN NEEDLE DIDN'T HAVE A LABEL/MISSING LABEL INFORMATION OR WAS ILLEGIBLE (ALL PACKAGING LEVELS). THIS EVENT OCCURRED 3 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRODUCT DID NOT HAVE A MANUFACTURING/EXPIRY DATE OR UDI (UNIQUE DEVICE IDENTIFIER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509122 BD ULTRA FINE¿ NANO¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 5161378 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Other