BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NANO¿ ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (90 COUNT)

    MDR report key: 15250596 · Received August 18, 2022

    Report

    Report Number
    9616656-2022-00862
    Event Type
    Malfunction
    Date Received
    August 18, 2022
    Date of Event
    July 25, 2022
    Report Date
    July 27, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 1243892 FOR NEEDLE CLOG (INJECTION). THIS IS THE 3RD RELATED COMPLAINT FOR NEEDLE CLOG (INJECTION) ON LOT # 1243892. RELATED COMPLAINTS - 4779894, 5156269. NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: UNCONFIRMED: EMBECTA WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING 10-15 BD NANO¿ ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (90 COUNT), MEDICATION COULD NOT BE DELIVERED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FINDING NEEDLES CLOG DURING INJECTION. FOUND 10-15 IN THIS BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530359 BD NANO¿ ULTRA-FINE¿ PEN NEEDLES 32G X 4MM (90 COUNT) HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1243892

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown