BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES

    MDR report key: 12448168 · Received September 9, 2021

    Report

    Report Number
    9617032-2021-00941
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 13, 2021
    Report Date
    September 22, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR FOREIGN MATTER (BLOOD) WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 100 RETENTION SAMPLES FROM EACH LOT FROM THE BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO FOREIGN MATTER (BLOOD) AS ALL SAMPLES MET SPECIFICATIONS. THE MANUFACTURING SITE DOES NOT USE BLOOD IN THE PRODUCTION AREAS THEREFORE, THE COMPLAINT CANNOT BE CONFIRMED DUE TO LACK OF ANY OBJECTIVE EVIDENCE. 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 FOREIGN MATTER (BLOOD). BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 400 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LAB-HEAD INFORMED US THE HEMOGARD-CLOSURES ARE CONTAMINATED WITH BLOOD. THE PACKAGING MATERIAL IS ALSO CONTAMINATED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1067152, MEDICAL DEVICE EXPIRATION DATE: 2022-07-31, DEVICE MANUFACTURE DATE: 2021-03-08, MEDICAL DEVICE LOT #: 1102369, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: 2021-04-12. 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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® BARRICOR¿ LH PLASMA BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED FOREIGN MATTER IN THE TUBE(S) BIOLOGICAL AND NON-BIOLOGICAL. THIS EVENT OCCURRED 400 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE LAB-HEAD INFORMED US THE HEMOGARD-CLOSURES ARE CONTAMINATED WITH BLOOD. THE PACKAGING MATERIAL IS ALSO CONTAMINATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344093 BD VACUTAINER BARRICOR LH PLASMA BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1