BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA

    MDR report key: 22868917 · Received August 21, 2025

    Report

    Report Number
    3024508819-2025-00276
    Event Type
    Malfunction
    Date Received
    August 21, 2025
    Date of Event
    July 22, 2025
    Report Date
    August 21, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    30382903294245
    PMA / PMN Number
    K190054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 PHYSICAL SAMPLES WERE RECEIVED HOWEVER THE INVESTIGATION WAS PERFORMED BASED ON THE PHOTO(S) PROVIDED. 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. EMBECTA WAS ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. NO DEFINITIVE ROOT CAUSE DETERMINED AT THIS TIME. 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 SITUATION ANALYSIS (SA) IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    ACCOUNT- (B)(6). SKU# UNKNOWN ITEM DESCRIPTION: BD INSULIN SYRINGE 1ML LOT# 3121576 QUANTITY- UNKNOWN. COUNTRY- USA INCIDENT DESCRIPTION- WE WANTED TO INFORM THE COMPANY THAT WE FOUND THIS BD INSULIN SYRINGE 1ML (LOT NO 3121576) WITH THE NEEDLE POKING THROUGH THE CAP. IT DID POKE ONE OF OUR ASSOCIATES. THE COMPANY MAY WANT TO INVESTIGATE INTO THIS. PLEASE CHECK THE ATTACHMENT FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189763 SYRINGE 1.0ML 28GA 1/2IN BLS 500 BDD CA Syringe, piston FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 329424 3121576 30382903294245

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown