BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ SHORT PEN NEEDLES

    MDR report key: 13334149 · Received January 24, 2022

    Report

    Report Number
    9616656-2022-00024
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 4, 2022
    Report Date
    February 2, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 07-FEB-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED (54) OPEN 31GX8MM BD PEN NEEDLES. DETACHED TEAR DROP LABELS FROM LOT# 1173026 AND 1202178 WERE RETURNED WITH THE SAMPLES. THE CONSUMER REPORTED THAT THE PATIENT END WILL NOT ATTACH TO THE INSULIN PEN. THE RETURNED SAMPLES WERE EXAMINED, AND IT WAS OBSERVED THAT 6 OUT OF THE 54 PEN NEEDLES FEATURED A BENT NON-PATIENT END (NPE) CANNULA. THE REMAINING 48 SAMPLES WERE TESTED FOR ATTACHMENT, AND ALL 48 WERE ABLE TO ATTACH TO A THREADED TEST FIXTURE PROPERLY. THE BENT NPE CANNULAS WOULD PREVENT THE PEN NEEDLES FROM PROPERLY ATTACHING TO A PEN INJECTOR. SINCE THE DEFECTIVE SAMPLES WERE RETURNED AFTER USE, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. 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. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (NPE CANNULA BENT). THE ROOT CAUSE FOR THIS ISSUE IS USER RELATED. THE NPE CANNULAS WERE BENT BY THE USER AFTER HANDLING THE PEN NEEDLES. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED BD ULTRA-FINE¿ SHORT PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED PATIENT END WILL NOT ATTACH TO INSULIN PEN."

    Description of Event or Problem · 0

    IT WAS REPORTED BD ULTRA-FINE¿ SHORT PEN NEEDLE WAS DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED PATIENT END WILL NOT ATTACH TO INSULIN PEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983162 BD ULTRA-FINE¿ SHORT PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 1202178 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown