BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEN NEEDL 31GA 8MM

    MDR report key: 12944091 · Received December 6, 2021

    Report

    Report Number
    9616656-2021-01482
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 8, 2021
    Report Date
    November 17, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403801518
    PMA / PMN Number
    K051641
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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. INVESTIGATION SUMMARY: NO SAMPLES WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED AT THIS TIME. A COMPLAINT LOT HISTORY CHECK WAS PERFORMED ON LOT # 0162428 FOR NEEDLE CLOG. THIS IS THE 1ST. RELATED COMPLAINT FOR NEEDLE CLOG.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PEN NEEDL 31GA 8MM, THE DEVICE EXPERIENCED THE INABILITY TO DELIVER INSULIN/MEDICATION AND A DAMAGED PRODUCT (STILL OPERABLE). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED NEEDLE CLOGGED. PATIENT END NEEDLE APPEARED TO BE FUSED CLOSED - NO VISIBLE "HOLE" PRESENT. CONSUMER STATED PATIENT END NEEDLE APPEARED TO BE FUSED CLOSED - NO VISIBLE "HOLE" PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1841552 BD PEN NEEDL 31GA 8MM HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8015 0162428 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown