BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 17959816 · Received October 18, 2023

    Report

    Report Number
    1024879-2023-00727
    Event Type
    Malfunction
    Date Received
    October 18, 2023
    Date of Event
    September 22, 2023
    Report Date
    November 27, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673001
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367300. LOT/BATCH #: 3090608. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION, UTILIZING A BORESCOPE TO SHINE LIGHT THROUGH THE CANNULA, AND NO ISSUES WERE OBSERVED RELATING TO INSUFFICIENT FLOW 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 INSUFFICIENT BLOOD FLOW. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THERE WAS INSUFFICIENT BLOOD FLOW. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: AT THE TIME OF THE BLOOD TEST THE BLOOD DOES NOT COME, TEST IMPOSSIBLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH THE BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THERE WAS INSUFFICIENT BLOOD FLOW. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: AT THE TIME OF THE BLOOD TEST THE BLOOD DOES NOT COME, TEST IMPOSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175813 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3090608 00382903673001

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown