BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19725140 · Received July 11, 2024

    Report

    Report Number
    3024508819-2024-00174
    Event Type
    Malfunction
    Date Received
    July 11, 2024
    Report Date
    September 30, 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: 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 UNABLE 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

    MATERIAL # 320440. MATERIAL DESCRIPTION - SYRINGE 0.3ML 31GA 8MM TW INSULIN 100EA/PK 5PK/CA. MATERIAL LOT# - 3240187. COMPLAINT DESCRIPTION: THE NURSE FOUND THE PLUNGERS WERE STICKING AND WHEN SHE WAS ABLE TO PULL THE PLUNGER BACK, THEY WERE SEPARATING FROM THE SYRINGE COMPLETELY AS PER THE PICTURE INCLUDED. NOTES: THE PRODUCT COMPLAINT MAIL HAS BEEN ATTACHED FOR FURTHER REFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315837 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 320440 3240187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose