BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 5ML S/T

    MDR report key: 11845994 · Received May 18, 2021

    Report

    Report Number
    1213809-2021-00339
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6), USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: BATCH 9212070 (301603) WAS MANUFACTURED EITHER IN 2009 OR EARLIER AND IS WELL PAST ITS SHELF LIFE. THIS PRODUCT IS NO LONGER IN PRODUCTION. IT IS POSSIBLE THE LABEL REQUIREMENT AT THE TIME IT WAS PRODUCED DID NOT INCLUDE EXPIRATION DATE ON THE PARTICULAR LABEL IN QUESTION. NO DEFECTS WERE CONFIRMED FOR THE ISSUES DESCRIBED IN THE COMPLAINT, THEREFORE NO ACTIONS ARE NECESSARY. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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 5ML S/T WAS MISSING THE EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO:301603. BATCH NO: 9212070. IT WAS REPORTED THAT THE EXPIRATION DATE WAS MISSING FROM THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741824 SYRINGE 5ML S/T SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9212070

    Patients

    Seq Age Sex Outcome Treatment
    1