BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32GA 4MM 100 BX 1200 CA

    MDR report key: 10860475 · Received November 18, 2020

    Report

    Report Number
    9616656-2020-01161
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 25, 2020
    Report Date
    November 20, 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
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 11/17/2020 H.6. INVESTIGATION: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 0022829. CUSTOMER RETURNED (9) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL OR OUTER COVER. CUSTOMER STATES THAT THE NEEDLES ARE CLOGGED. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 6 OUT OF 9 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM PROPERLY FLOWING THROUGH THE CANNULA. 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. ROOT CAUSE IS USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 13 PEN NDL 32GA 4MM 100 BX 1200 CA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES ARE CLOGGED VERBATIM: CONSUMER REPORTED, WHEN PRIMING, NO INSULIN FLOWS STATED, SHE HAS BEEN USING PRODUCT FOR 3 YEARS AND EVERY BOX THAT WAS USED, HAD THE PROBLEM".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0022829, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2020-01-22, MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. 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 13 PEN NDL 32GA 4MM 100 BX 1200 CA WERE UNABLE TO DELIVER MEDICATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES ARE CLOGGED. VERBATIM: CONSUMER REPORTED, WHEN PRIMING, NO INSULIN FLOWS. STATED, SHE HAS BEEN USING PRODUCT FOR 3 YEARS AND EVERY BOX THAT WAS USED, HAD THE PROBLEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1323856 PEN NDL 32GA 4MM 100 BX 1200 CA HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 SEE H.10. 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1