BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM 100BX 1200 USA

    MDR report key: 10898222 · Received November 24, 2020

    Report

    Report Number
    9616656-2020-01178
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 29, 2020
    Report Date
    December 11, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FRN
    UDI-DI
    00382903201228
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    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: 11/18/2020 H.6. INVESTIGATION: CUSTOMER RETURNED (16) OPEN 4MM, 32G PEN NEEDLES WITHOUT THE TEAR DROP LABEL IN A SHELF CARTON FROM LOT # 0022825. CUSTOMER STATES THAT SOME PEN NEEDLES DO NOT RELEASE MEDICATION DURING PRIMING. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 12 OUT OF 16 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA, WHICH COULD PREVENT INSULIN FROM FLOWING THROUGH THE CANNULA. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION AND THE INNER SHIELD WOULD NOT DETACH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE STUCK IN INNER SHIELD AND SOME PEN NEEDLES DO NOT RELEASE MEDICATION DURING PRIMING. VERBATIM: CONSUMER REPORTED HAVING ABOUT A QUARTER OF A ZIP LOC BAG WITH PEN NEEDLES THAT ARE BAD. STATED SOME OF THE NEEDLES ARE STUCK IN THE INNER SHIELD SO SHE IS UNABLE TO USE THOSE PEN NEEDLES. STATED SOME OF THE PEN NEEDLES DO NOT RELEASE MEDICATION DURING PRIMING. CONSUMER DOES NOT RE-USE ."

    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 A PEN NDL 32G 4MM 100BX 1200 USA WAS UNABLE TO DELIVER MEDICATION AND THE INNER SHIELD WOULD NOT DETACH DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT NEEDLES ARE STUCK IN INNER SHIELD AND SOME PEN NEEDLES DO NOT RELEASE MEDICATION DURING PRIMING. VERBATIM: CONSUMER REPORTED HAVING ABOUT A QUARTER OF A ZIP LOC BAG WITH PEN NEEDLES THAT ARE BAD. STATED SOME OF THE NEEDLES ARE STUCK IN THE INNER SHIELD SO SHE IS UNABLE TO USE THOSE PEN NEEDLES. STATED SOME OF THE PEN NEEDLES DO NOT RELEASE MEDICATION DURING PRIMING. CONSUMER DOES NOT RE-USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362792 PEN NDL 32G 4MM 100BX 1200 USA HYPODERMIC SINGLE LUMEN NEEDLE FRN BECTON DICKINSON AND CO. 320122 0022825 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1