BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS

    MDR report key: 19533337 · Received June 13, 2024

    Report

    Report Number
    3024508819-2024-00119
    Event Type
    Malfunction
    Date Received
    June 13, 2024
    Date of Event
    May 22, 2024
    Report Date
    September 3, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00382908468039
    PMA / PMN Number
    K190054
    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.

    Description of Event or Problem · 0

    PHARMACY REPORTED PRODUCT BELIEVE TO BE EXPIRED. BUT NO EXP DATE ON THE BOX FOUND. FROM INFORMATION RECEIVED, LOT # AND ITEM NUMBER PLUS COPY DATE, ITEM IS EXPIRED. DC. LOT # 4230609. CATALOG# 328468. DATE OF EVENT 05.22.2024. SAMPLE STATUS DISCARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1124014 SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328468 4230609 00382908468039

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown