BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 11750185 · Received April 29, 2021

    Report

    Report Number
    9616656-2021-00451
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 31, 2021
    Report Date
    April 8, 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
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ""MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0092500, MEDICAL DEVICE EXPIRATION DATE: 2025-04-30, DEVICE MANUFACTURE DATE: 2020-05-18. MEDICAL DEVICE LOT #: 0260316, MEDICAL DEVICE EXPIRATION DATE: 2025-09-30, DEVICE MANUFACTURE DATE: 2020-09-16. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: 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. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLE CLOGGED DURING INJECTION. VERBATIM: CONSUMER REPORTED NEEDLE CLOG DURING INJECTION, STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. CONSUMER REFUSED VOUCHER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644399 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 SEE H.10. 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1