BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT)

    MDR report key: 17927509 · Received October 12, 2023

    Report

    Report Number
    1213809-2023-01138
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 22, 2023
    Report Date
    May 23, 2024
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K182320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT MDR PR# 8963538 WAS SENT IN ERROR. COMPLAINT CAPTURED UNDER REPORT MDR PR# 8963544 MFR#1213809-2023-01137. MFR#: 1213809-2023-01138 IS VOID AS A RESULT.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 2320078. D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027. H4. DEVICE MANUFACTURE DATE: 16-NOV-2022. D4. MEDICAL DEVICE LOT #: 2327547. D4. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2027. H4. DEVICE MANUFACTURE DATE: 16-NOV-2022. D4. MEDICAL DEVICE LOT #: 3004043. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2027. H4. DEVICE MANUFACTURE DATE: 04-JAN-2022. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL#:320550, LOT#: 2320078, 2327547, 3004043. IT WAS REPORTED BY THE CONSUMER TRIED TO PRIME 2 UNITS BUT WAS UNSUCCESSFUL. NON PATIENT END WAS NOT BENT BEFORE OR AFTER TRYING TO PRIME. CONSUMER STATED, THERE WAS NO INSULIN FLOW WHEN PRIMING. VERBATIM: FROM PHONE CALL ON 2023-09-22 10:58:07: LOT: 2320078,(ONE BOX) 2327547,(ONE BOX) 3004043, (TWO BOXES) FOUR BOXES OF PEN NEEDLES IN TOTAL. ASSISTED CONSUMER OVER THE PHONE WITH ATTEMPTING TO PRIME PEN NEEDLES. CONSUMER TRIED TO PRIME 2 UNITS BUT WAS UNSUCCESSFUL. NON PATIENT END WAS NOT BENT BEFORE OR AFTER TRYING TO PRIME. CONSUMER STATED, THERE WAS NO INSULIN FLOW WHEN PRIMING. CATALOG: 320550. DATE OF EVENT: (B)(6) 2023. 6 PEN NEEDLES FAILED TO PRIME. SAMPLES: YES. CONSUMER STATED, SHE WILL REACH OUT TO THE MANUFACTURE OF MEDICATION. CL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) THE MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT: 2320078,(ONE BOX) 2327547,(ONE BOX) 3004043, (TWO BOXES) FOUR BOXES OF PEN NEEDLES IN TOTAL. ASSISTED CONSUMER OVER THE PHONE WITH ATTEMPTING TO PRIME PEN NEEDLES. CONSUMER TRIED TO PRIME 2 UNITS BUT WAS UNSUCCESSFUL. NON PATIENT END WAS NOT BENT BEFORE OR AFTER TRYING TO PRIME. CONSUMER STATED, THERE WAS NO INSULIN FLOW WHEN PRIMING. CATALOG: 320550. DATE OF EVENT: (B)(6) 2023, (B)(6) 2023 PEN NEEDLES FAILED TO PRIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704338 BD NANO¿ 2ND GEN PEN NEEDLES 32G X 4MM (100 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 3004043 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown