BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19315261 · Received May 14, 2024

    Report

    Report Number
    3024508819-2024-00055
    Event Type
    Malfunction
    Date Received
    May 14, 2024
    Report Date
    August 8, 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

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H3, H11. CORRECTION TO: H6 (MEDICAL DEVICE CODE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) 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. 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 - DERMETICS ONTARIO CANADA MATERIAL - SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA MATERIAL# - 320440 LOT# - 4002004 COMPLAINT - WE HAVE NOT NOTICED THIS FLUID COMING FROM NEW SYRINGES BEFORE. THE FLUID FEELS SLIPPERY AND VISCOUS, NOT LIKE WATER, BUT LIKE AN OILY TEXTURE. ALSO, TO REITERATE WHAT I SAID ON THE PHONE, WE ARE AN EXTREMELY HIGH-VOLUME CLINIC, AND NEED TO HAVE THIS MATTER INVESTIGATED AND ADDRESSED AS PRIORITY. YOU HELP IN ESCALATING THIS MATTER AND FACILITATING A PROMPT RESPONSE IS VERY APPRECIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1102795 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 320440 4002004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown