BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER

    MDR report key: 14214261 · Received April 26, 2022

    Report

    Report Number
    2618282-2022-00020
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 11, 2022
    Report Date
    May 2, 2022
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1172404 MEDICAL DEVICE EXPIRATION DATE: 2024-06-30 DEVICE MANUFACTURE DATE: 2021-08-12 . MEDICAL DEVICE LOT #: 1156553 . MEDICAL DEVICE EXPIRATION DATE: 2024-05-31 DEVICE MANUFACTURE DATE: 2021-07-21 MEDICAL DEVICE LOT #: 1126023 . MEDICAL DEVICE EXPIRATION DATE: 2024-04-30 DEVICE MANUFACTURE DATE: 2021-07-07 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

    H6: INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES FOR INVESTIGATION. THE SAMPLES WERE WASHED AND EVALUATED BY FUNCTIONAL TESTING, EACH USED TO TRANSFER COLORED WATER FROM A SYRINGE TO A TUBE, AND THE INDICATED FAILURE MODE FOR INSUFFICIENT FLOW WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 12 RETENTION SAMPLES OF EACH REPORTED LOT NUMBER (36 TOTAL) FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH TESTED FOR LEAKAGE AND CLOGS, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THE TUBE WAS UNABLE TO BE FILLED, BLOOD NOT TRANSFERRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLOOD WAS NOT TRANSFERRED WITH BTD."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER THE TUBE WAS UNABLE TO BE FILLED, BLOOD NOT TRANSFERRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "BLOOD WAS NOT TRANSFERRED WITH BTD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1529118 BD VACUTAINER® BLOOD TRANSFER DEVICE HOLDER WITH FEMALE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BD CARIBE LTD. 364880 SEE H.10 50382903648806

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown