BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 12749589 · Received November 3, 2021

    Report

    Report Number
    9614033-2021-00129
    Event Type
    Malfunction
    Date Received
    November 3, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 13, 2021
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: ONE 3ML SYRINGE RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION OF THE SAMPLE NO DEFECTS CAN BE OBSERVED. BARREL DOES NOT PRESENT ANY DAMAGE THAT COULD HAVE DEFORMED THEIR SHAPE. FUNCTIONAL TESTING IS PERFORMED WITH BD MAX ZERO, NO LEAKAGE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1131289, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL 200 S/C LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED ENCOUNTERED A LEAK WHILE USING BD 3 ML LUER LOCK SYRINGE WHEN ATTACHED TO THE BD MAXZERO MICROBORE EXTENSION SET TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1645513 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF 1131289 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1