BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA FINE PEN NEEDLE

    MDR report key: 10551449 · Received September 17, 2020

    Report

    Report Number
    9616656-2020-00930
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 8, 2020
    Report Date
    September 11, 2020
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403928659
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: 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 CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. OCCURRENCE: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE CLOG ON LOT # 0022825. A REVIEW OF RISK MANAGEMENT DOCUMENT (B)(4), INDICATES THAT THE POTENTIAL RISK OF THIS SPECIFIC REPORTED INCIDENT (PEN NEEDLE, NEEDLE CLOG) WAS CAPTURED AND ADDRESSED. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME AS THE ISSUE IS UNCONFIRMED AS NO SAMPLES OR PHOTOS WERE RETURNED. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD ULTRA FINE¿ PEN NEEDLE WAS CLOGGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CONSUMER REPORTED FINDING ABOUT 50 % FROM THIS BOX OF PEN NEEDLES CLOG DURING INJECTION. INFORMED OF PROPER PLACEMENT AND TO COMPLETE FLOW CHECK WITH ALL INJECTIONS. SHE COMPLETES FLOW CHECK ONLY WITH SOME INJECTIONS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016055 BD ULTRA FINE PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 2865 0022825 10885403928659

    Patients

    Seq Age Sex Outcome Treatment
    1 Other