BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18912793 · Received March 15, 2024

    Report

    Report Number
    1920898-2024-05058
    Event Type
    Malfunction
    Date Received
    March 15, 2024
    Report Date
    June 11, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949
    Product Code
    FMF
    PMA / PMN Number
    3367
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    3 SYRINGES AFFECTED BY THIS EVENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS ADDED TO: H11. MEDWATCH SECTION C FOR AFFECTED PRODUCT IS ATTACHED. CORRECTION TO E1 (COUNTRY TYPE, COUNTRY), H6 (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 ABLE TO DUPLICATE OR CONFIRM THE INDICATED ISSUE AS MEDICAL GRADE SILICON 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.

    Description of Event or Problem · 0

    CONSUMER REPORTED FOUND 3 SYRINGES FROM THIS BOX WITH LIQUID COMING OUT OF THE NEEDLE BEFORE USE. DC. LOT # 3240187. CATALOG# 320440. DATE OF EVENT UNKNOWN . SAMPLE STATUS AWAITING SAMPLE. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320006 SYRINGE 0.3ML 31GA 8MM TW 10BAG 500 CA SYRINGE, PISTON FMF BD MEDICAL - DIABETES CARE - HOLDREGE, NE / 68949 320440 3240187

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown