BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL

    MDR report key: 18488618 · Received January 10, 2024

    Report

    Report Number
    1920898-2024-05004
    Event Type
    Malfunction
    Date Received
    January 10, 2024
    Date of Event
    December 17, 2023
    Report Date
    April 12, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    UDI-DI
    00681131311786
    PMA / PMN Number
    K212499
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THIS IS THE 1ST COMPLAINT FOR THE REPORTED LOT NUMBER. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED, AND NO NON-CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS TYPE OF EVENT FOR THIS LOT. 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.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : NOT AVAILABLE.

    Description of Event or Problem · 0

    CONSUMER REPORTED REUSING SYRINGE 4 TIMES A DAY FOR 4 DAYS. THIS SAME SYRINGE BROKE OFF IN RIGHT UPPER THIGH IN LAST NIGHTS INJECTION. CAN'T FIND/SEE IT IN HER SITE. NOR ON THE FLOOR. INFORMED CALLER REASONS NOT TO REUSE. SHE HAS NOT SEEN MEDICAL ATTENTION AS OF YET. NOT SURE IF SHE WILL. - DC LOT # 3191935 CATALOG# 328512 DATE OF EVENT DECEMBER 17, 2023 SAMPLE STATUS DISCARD (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    730709 SYRINGE 0.3ML 31GA 8MM 10BAG 500 WAL SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 328512 3191935 00681131311786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female