BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 18847161 · Received March 6, 2024

    Report

    Report Number
    1920898-2024-05052
    Event Type
    Malfunction
    Date Received
    March 6, 2024
    Date of Event
    February 6, 2024
    Report Date
    May 29, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    CORRECTION TO H6, TYPE OF INVESTIGATION, INVESTIGATION CONCLUSIONS 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. 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

    COMPLAINT - "THEY MENTIONED THAT THERE ARE BLACK PARTICLES INSIDE THE SYRINGE." NOTE - CUSTOMER IS LOOKING TO GET AN NDA FORM TO DISCUSS THE MANUFACTURING INCIDENT THEY ARE EXPERIENCING WITH ONE OF OUR SYRINGES. CUSTOMER WANTS TO FIRST GET AN NDA FORM SIGNED BEFORE SHARING ANY OTHER INFORMATION IN REGARD TO THE COMPLAINT OR MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117653 UNKNOWN SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown