BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER

    MDR report key: 15844086 · Received November 22, 2022

    Report

    Report Number
    2618282-2022-00077
    Event Type
    Malfunction
    Date Received
    November 22, 2022
    Date of Event
    November 2, 2022
    Report Date
    July 15, 2024
    Manufacturer
    BD CARIBE LTD.
    Product Code
    JKA
    UDI-DI
    50382903648806
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: MATERIAL #: 36488000. LOT/BATCH #: 2140080. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 48 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND 12 BY FUNCTIONAL TESTING, MEASURING THE FORCE NEEDED TO BREAK / UNSEAT THE NEEDLE SUB-ASSEMBLY FROM THE HOLDER, AND NO ISSUES WERE OBSERVED RELATING TO HUB SEPARATION 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 HUB SEPARATION. 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 VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE HCP WAS WORKING ON BTD ATTACHED TO A SYRINGE IN A BLOOD COLLECTION ROOM, THE SYRINGE WAS SEPARATED, FLYING OFF, WITH BLOOD ADHERING TO THE CURTAIN."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THE HUB SEPARATED FROM THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN THE HCP WAS WORKING ON BTD ATTACHED TO A SYRINGE IN A BLOOD COLLECTION ROOM, THE SYRINGE WAS SEPARATED, FLYING OFF, WITH BLOOD ADHERING TO THE CURTAIN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2707348 BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 364880 2140080 50382903648806

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown