BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN

    MDR report key: 19139503 · Received April 18, 2024

    Report

    Report Number
    3024508819-2024-00003
    Event Type
    Malfunction
    Date Received
    April 18, 2024
    Date of Event
    March 20, 2024
    Report Date
    July 9, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLES WERE RECEIVED AND AN INVESTIGATION WAS PERFORMED. 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 NOT ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND CORRECTIVE/PREVENTATIVE ACTION (CAPA) OR SITUATIONAL ANALYSIS (SA) IS REQUIRED.

    Description of Event or Problem · 0

    PER EMAIL RECEIVED: "SCALE MARKING DEFECTIVE. INACCURATE SCALE MARKINGS. LOT: 3142983. CATALOG: 328822. SAMPLES: YES CL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242463 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 TWN SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 328822 3142983

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown