BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE MICRO PEN NEEDLE

    MDR report key: 11528824 · Received March 19, 2021

    Report

    Report Number
    9616656-2021-00290
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    February 23, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. DUE TO BATCH BEING UNKNOWN, NO DHR CAN BE COMPLETED. A LOT HISTORY REVIEW WAS CARRIED OUT ON LOT#0112358 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 3 BD ULTRA-FINE¿ MICRO PEN NEEDLES FROM LOT 0112358, AND 1 NEEDLE FROM AN UNSPECIFIED LOT CLOGGED DURING THEIR INJECTIONS AND FAILED TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLES CLOG DURING INJECTION TOOK CONSUMER 3 PEN NEEDLES FOR ONE INJECTION THIS MORNING- CONSUMER DOES NOT COMPLETE A FLOW CHECK."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0112358, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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

    IT WAS REPORTED THAT 3 BD ULTRA-FINE¿ MICRO PEN NEEDLES FROM LOT 0112358, AND 1 NEEDLE FROM AN UNSPECIFIED LOT CLOGGED DURING THEIR INJECTIONS AND FAILED TO DELIVER MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED NEEDLES CLOG DURING INJECTION TOOK CONSUMER 3 PEN NEEDLES FOR ONE INJECTION THIS MORNING- CONSUMER DOES NOT COMPLETE A FLOW CHECK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425807 BD ULTRA-FINE MICRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1