BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ 2ND GEN PEN NEEDLE

    MDR report key: 16615261 · Received March 24, 2023

    Report

    Report Number
    9616656-2023-00272
    Event Type
    Malfunction
    Date Received
    March 24, 2023
    Date of Event
    March 7, 2023
    Report Date
    June 22, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903205509
    PMA / PMN Number
    K212015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES,. D10: RETURNED TO MANUFACTURER ON: 22-MAR-2023. H6: INVESTIGATION SUMMARY: CUSTOMER RETURNED 87 UNOPENED 32G 4MM PRO PEN NEEDLES IN A SHELF CARTON FROM LOT# 2200706 AND 3 OPENED 32G 4MM PRO PEN NEEDLES LOOSE. IT WAS REPORTED BY CUSTOMER THAT " PEN NEEDLE WILL NOT ATTACH TO THE INSULIN PEN." ALL THE RETURNED PEN NEEDLES WERE VISUALLY INSPECTED AND OBSERVED NO ISSUES. PEN NEEDLES (30) WERE ATTACHED AND DETACHED USING PEN INJECTOR AND OBSERVED NO DEFECTS WITH ATTACH/DETACH. HENCE, ALLEGED ISSUE COULD NOT BE CONFIRMED BASED ON THE SAMPLES RETURN FOR THE INVESTIGATION. 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. BASED ON THE SAMPLE RECEIVED, EMBECTA WAS NOT ABLE TO CONFIRM THE CUSTOMER INDICATED FAILURE. THE ROOT CAUSE CANNOT BE DETERMINED AS THE ISSUE IS UNCONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WOULD NOT ATTACH TO THE INSULIN PEN DUE TO THE HUB SPINNING AND NOT TIGHTENING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE PEN NEEDLE WILL NOT ATTACH TO THE INSULIN PEN. HE STATED THAT THE NEEDLE HUB SPINS AND WILL NOT TIGHTEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NANO¿ 2ND GEN PEN NEEDLE WOULD NOT ATTACH TO THE INSULIN PEN DUE TO THE HUB SPINNING AND NOT TIGHTENING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED THAT THE PEN NEEDLE WILL NOT ATTACH TO THE INSULIN PEN. HE STATED THAT THE NEEDLE HUB SPINS AND WILL NOT TIGHTEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376439 BD NANO¿ 2ND GEN PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320550 2200706 00382903205509

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown