BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ULTRA-FINE¿ MINI PEN NEEDLES

    MDR report key: 13998813 · Received April 4, 2022

    Report

    Report Number
    9616656-2022-00378
    Event Type
    Malfunction
    Date Received
    April 4, 2022
    Date of Event
    March 10, 2022
    Report Date
    March 18, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    UDI-DI
    10885403811012
    PMA / PMN Number
    K162516
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1202184. MEDICAL DEVICE EXPIRATION DATE: 2026-07-31. DEVICE MANUFACTURE DATE: 2021-07-21. . MEDICAL DEVICE LOT #: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A DEVICE HISTORY RECORD COULD NOT BE COMPLETED AS NO LOT NUMBER WAS RECEIVED. 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. 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 6 BD ULTRA-FINE¿ MINI PEN NEEDLES WERE NOT FUNCTIONING CORRECTLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "...PEN NEEDLES WOULD NOT SCREW ONTO PEN...".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811237 BD ULTRA-FINE¿ MINI PEN NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 8110 SEE H.10. 10885403811012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown