BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ NANO¿ PEN NEEDLES

    MDR report key: 15564625 · Received October 7, 2022

    Report

    Report Number
    9616656-2022-01098
    Event Type
    Malfunction
    Date Received
    October 7, 2022
    Date of Event
    September 16, 2022
    Report Date
    December 27, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    00382903201228
    PMA / PMN Number
    K213478
    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: 30-SEP-2022. H6: INVESTIGATION SUMMARY CUSTOMER RETURNED A TOTAL OF (20) 4MM, 32 GAUGE NANO PEN NEEDLES FROM LOT 4056223 AND (19) 4MM, 32 GAUGE NANO PEN NEEDLES FROM LOT 4043139. PULLING EACH OF THE NEEDLE SHIELDS FROM THE PEN NEEDLES DID NOT REQUIRE ANY MORE FORCE THAN ANTICIPATED. EACH NEEDLE SHIELD COULD BE REMOVED WITH LITTLE EFFORT AS INTENDED. NEEDLE STICKS ARE LIABLE TO HAPPEN IN THE EVENT OF RESHIELDING. THE PEN NEEDLES ARE A SINGLE-USE ITEM AND NOT INTENDED TO BE RESHIELDED ONCE THE NEEDLE SHIELD IS REMOVED. 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 SAMPLES RECEIVED, EMBECTA WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE OF THE INNER SHIELDS HAVING INCORRECT DIMENSIONS. ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4043139, MEDICAL DEVICE EXPIRATION DATE: 15MAR2019, DEVICE MANUFACTURE DATE: 15MAR2014. 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

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES THE SHIELDS WERE DIFFICULT TO REMOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED INNER SHIELDS ARE HARD TO REMOVE BECAUSE THEY ARE TOO SMALL.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD ULTRA-FINE¿ NANO¿ PEN NEEDLES THE SHIELDS WERE DIFFICULT TO REMOVE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER STATED INNER SHIELDS ARE HARD TO REMOVE BECAUSE THEY ARE TOO SMALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2887918 BD ULTRA-FINE¿ NANO¿ PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 320122 4056223 00382903201228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown