BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 10BAG 500 PL/WG

    MDR report key: 19513822 · Received June 11, 2024

    Report

    Report Number
    3024508819-2024-00109
    Event Type
    Malfunction
    Date Received
    June 11, 2024
    Report Date
    August 28, 2024
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    UDI-DI
    00311917025278
    PMA / PMN Number
    K212499
    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 ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS AND BASED ON TREND ANALYSIS NO FURTHER ACTION IS REQUIRED AT THIS TIME. THE RESULT OF THE FTIR CONCLUDES THE MATERIAL BEING A MEDICAL GRADE LUBRICANT, WHICH IS USED AS A MATERIAL IN OUR PROCESS TO EXERCISE THE SMOOTH MOVEMENT OF A PLUNGER IN THE SYRINGE. 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

    PET OWNER REPORTED PUSHING CLEAR LIQUID FROM THE BARREL ONTO THE NEEDLE PRIOR TO INJECTION. STATED, DOES NOT USE THE SYRINGES WITH CLEAR LIQUID. LOT: 2234067. CATALOG: 928855. DATE OF EVENT: UNKNOWN. SAMPLES: YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9283 SYRINGE 0.3ML 30GA 8MM 10BAG 500 PL/WG SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 928855 2234067 00311917025278

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown