BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II SYRINGE

    MDR report key: 14749825 · Received June 20, 2022

    Report

    Report Number
    2243072-2022-00831
    Event Type
    Malfunction
    Date Received
    June 20, 2022
    Date of Event
    May 21, 2022
    Report Date
    June 1, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS THE MFR SITE AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. TWO PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF ITEM #: 301285 FROM LOT#: 2012403 REGARDING THE REPORTED ISSUE OF BLOOD LEAKAGE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR BLOOD LEAKAGE AND NO BLOOD LEAKAGE WAS FOUND IN THE TEN RETENTION SAMPLES. SINCE NO SAMPLE AND TWO PHOTOGRAPHS RECEIVED WERE NOT HELPFUL TO INVESTIGATE FURTHER, THE COMPLAINT COULD NOT BE CONFIRMED, AND INVESTIGATION COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT¿ II SYRINGE HAD A LEAKAGE PROBLEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF THE CUSTOMERS HAS COMPLAINED THE ISSUE OVER TELEPHONE THAT BLOOD WAS COMING OUT FROM THE SYRINGES DURING THE TIME OF BLOOD COLLECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261289 BD DISCARDIT¿ II SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2012403

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown