BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1.0ML 30GA 8MM 10BAG 500CAS AP

    MDR report key: 21244234 · Received January 27, 2025

    Report

    Report Number
    3024508819-2025-00059
    Event Type
    Malfunction
    Date Received
    January 27, 2025
    Date of Event
    January 8, 2025
    Report Date
    March 5, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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. CAPA PR00034 WAS OPENED TO ADDRESS ILLEGIBLE/PARTIAL LABELLING ON PACKAGING. 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.

    Additional Manufacturer Narrative · 0

    38 POLYBAGS IMPACTED FROM LOT # 3233276. SEE SECTION C FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    38 POLY BAGS UNCLEAR INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758958 SYRINGE 1.0ML 30GA 8MM 10BAG 500CAS AP SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328818 3233276

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose