BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG

    MDR report key: 21805973 · Received April 9, 2025

    Report

    Report Number
    3024508819-2025-00171
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Report Date
    April 9, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    K992734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MEDWATCH SUBMISSION IS BOTH AN INITIAL AND SUPPLEMENTAL FILING. INVESTIGATION OF THE RESULTS CAN BE SEEN BELOW: 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

    MATERIAL # 305935. MATERIAL DESCRIPTION - SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG. MATERIAL LOT# - 4163120. COMPLAINT DESCRIPTION ¿ THIS AFTERNOON ONE OF THE NURSES WORKING ON 5E WAS PREPARING TO DRAW UP INSULIN FROM A VIAL FOR A PATIENT. SHE SAID WHEN SHE PULLED THE CAP OFF OF THE SYRINGE THE ENTIRE SAFETY ALSO CAME OFF OF THE SYRINGE LEAVING JUST THE NEEDLE EXPOSED WITH NO SAFETY MECHANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415083 SYRINGE 0.3ML 29GA 1/2IN BLS 400 SG Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 305935 4163120

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown