BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP

    MDR report key: 20599875 · Received November 4, 2024

    Report

    Report Number
    3024508819-2024-00424
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 15, 2024
    Report Date
    January 13, 2025
    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

    CORRECTIONS MADE TO SECTION H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & 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-CONFORMANCE'S 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. CAPA: PR00034 WAS OPENED IN JULY 2024 TO ADDRESS ILLEGIBLE/PARTIAL LABELING ON PACKAGING.

    Additional Manufacturer Narrative · 0

    5 UNITS IMPACTED FROM LOT # 3142108. SEE SECTION C FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    THE NEEDLE IS COVERED BY CAP AND THE GLUE IS COLORLESS, IT IS VERY HARD FOR WORKERS TO FIND THE ISSUE AND PICK IT OUT DURING MASS PRODUCTION. NOTE: AS PER ATTACHMENT COUNTRY EVENT MENTIONED AS AU. BUT EMAIL RECEIVED FROM MALAYSIA. AWARENESS DATE AS 09-SEP-2024 BUT EMAIL RECEIVED ON 15-OCT-2024. 18OCTOBER2024: PLEASE BE INFORMED THAT THE ARRIVAL STOCKS IN THE TABLE BELOW WERE FOUND 5 EA WITHOUT BATCH AND EXPIRY DATE ON PHYSICAL STOCK DURING REDRESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789225 SYRINGE 0.5CCM 30GA 8MM BLS 100BX/500 AP SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 326725 3142108

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown