BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 11205941 · Received January 20, 2021

    Report

    Report Number
    9616656-2021-00055
    Event Type
    Malfunction
    Date Received
    January 20, 2021
    Date of Event
    December 30, 2020
    Report Date
    February 25, 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
    IL, 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 PEN NDL 32G 4MM 100BX 1200 USA WOULD NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122, BATCH NO: 0014202. IT WAS REPORTED THAT THE CUSTOMER HAD QUITE A FEW SHARPS THAT DID NOT WORK. VERBATIM: EMAIL RECEIVED: 2020-12-30 09:45:05. I'VE BEEN USING YOUR SHARPS FOR OVER A YEAR NOW. WHEN I PICKED UP MY NEW BOX YESTERDAY I ASKED IF THEY DEALT WITH ANOTHER SUPPLIER. THE LAST BOX OF 90 I PICKED UP I HAD QUITE A FEW SHARPS THAT DID NOT WORK. INITIALLY I THOUGHT IT WAS THE PEN SO I THREW THE ENTIRE PEN OUT. MY STUPIDITY. THE NEXT TIME IT HAPPENED I TRIED ANOTHER SHARP WHEN I REALIZED THAT WAS THE PROBLEM I WAS QUITE RELIEVED HOWEVER THE SHARPS ARE STILL COSTLY. I AM ALSO CURIOUS AS TO WHY A CONTAINER TO DISPOSE OF THE SHARPS RESPONSIBLY IS NOT AUTOMATICALLY SUPPLIED WHEN THE SHARPS ARE PRESCRIBED AND DISPENSED TO A PATIENT. I'LL AWAIT YOUR RESPONSE BEFORE I TALK TO MY INSURANCE COMPANY TO SEE WHAT MY OPTIONS ARE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM 100BX 1200 USA WOULD NOT WORK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 320122, BATCH NO: 0014202. IT WAS REPORTED THAT THE CUSTOMER HAD QUITE A FEW SHARPS THAT DID NOT WORK. VERBATIM: EMAIL RECEIVED¿2020-12-30 09:45:05 I'VE BEEN USING YOUR SHARPS FOR OVER A YEAR NOW. WHEN I PICKED UP MY NEW BOX YESTERDAY I ASKED IF THEY DEALT WITH ANOTHER SUPPLIER. THE LAST BOX OF 90 I PICKED UP I HAD QUITE A FEW SHARPS THAT DID NOT WORK. INITIALLY I THOUGHT IT WAS THE PEN SO I THREW THE ENTIRE PEN OUT. MY STUPIDITY. THE NEXT TIME IT HAPPENED I TRIED ANOTHER SHARP WHEN I REALIZED THAT WAS THE PROBLEM I WAS QUITE RELIEVED HOWEVER THE SHARPS ARE STILL COSTLY. I AM ALSO CURIOUS AS TO WHY A CONTAINER TO DISPOSE OF THE SHARPS RESPONSIBLY IS NOT AUTOMATICALLY SUPPLIED WHEN THE SHARPS ARE PRESCRIBED AND DISPENSED TO A PATIENT. I'LL AWAIT YOUR RESPONSE BEFORE I TALK TO MY INSURANCE COMPANY TO SEE WHAT MY OPTIONS ARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102006 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 0014202 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1