BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP

    MDR report key: 20819844 · Received December 2, 2024

    Report

    Report Number
    3024508819-2024-00465
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    November 11, 2024
    Report Date
    June 26, 2025
    Manufacturer
    EMBECTA MEDICAL I LLC - HOLDREGE, NE
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED TO SECTIONS B4, G6, H2, H3, AND H11. SEE MEDWATCH COMPLETED SECTION C FORM ATTACHED. CORRECTIONS MADE TO SECTIONS D1 (BRAND NAME), D4 (MODEL NUMBER, LOT NUMBER, EXPIRATION DATE, & PRIMARY UNIQUE DEVICE IDENTIFICATION (USI) NUMBER) AND H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, & INVESTIGATION CONCLUSIONS). 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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: B4, G6, H2, H11. CORRECTION TO: H6 (INVESTIGATION FINDINGS). INVESTIGATION SUMMARY: ADDITIONAL INFORMATION RECEIVED, SITUATION ANALYSIS EMBC-25-0002-SA WAS OPENED TO ADDRESS THIS COMPLAINT.

    Additional Manufacturer Narrative · 0

    7 POLYBAGS IMPACTED FROM AN UNKNOWN LOT #. SEE SECTION C FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    WHEN DID IT OCCUR? BEFORE USE. NEEDLE INJURY: NO. OTHER TREATMENT: NO. WERE THE RETURNED ITEMS USED? NO. IF USED, WAS ANYTHING ADHERED TO IT? RETURNED QUANTITY: (B)(4). DETAILS OF THE EVENT (TIMELINE, HISTORY, ETC.): 26631 LOW DOSE 29G HAD SEVEN BAGS OF 326638 LOW DOSE 30G STANDARD. BATCH # UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304863 SYRINGE 0.3ML 30GA 8MM 7BAG 420CAS JP SYRINGE, PISTON FMF EMBECTA MEDICAL I LLC - HOLDREGE, NE 326638 4037008

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown