BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 15528716 · Received October 3, 2022

    Report

    Report Number
    9617032-2022-00980
    Event Type
    Malfunction
    Date Received
    October 3, 2022
    Date of Event
    August 14, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 364314. LOT/BATCH #: 2041496. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO MISSING IV SHIELD AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE MISSING IV SHIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE THE BLOOD COLLECTOR OPENED THE PACKAGE AND FOUND THE COVER MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: ¿WHEN PREPARING THE PATIENT FOR ARTERIAL BLOOD COLLECTION, THE BLOOD COLLECTOR WAS OPENED AND NEEDLE COVER WAS MISSING.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2337271 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2041496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown