BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBE

    MDR report key: 14214273 · Received April 26, 2022

    Report

    Report Number
    9617032-2022-00424
    Event Type
    Malfunction
    Date Received
    April 26, 2022
    Date of Event
    April 25, 2022
    Report Date
    May 20, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991120
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL LOT #: 1130431 DOES NOT EXIST FOR MATERIAL NUMBER 367599. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD DID NOT RECEIVE SAMPLES OR PHOTOGRAPHS FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE TUBES HAS EXPIRED (JANUARY 2022). BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. THE DEVICE HISTORY RECORDS WERE REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CTAD BLOOD COLLECTION TUBES DEVICE EXPERIENCED UNDERFILL OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TUBE DOES NOT FILL PROPERLY TO THE TOP: THE PATIENT HAD TO BE PRICKED SEVERAL TIMES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® CTAD BLOOD COLLECTION TUBES DEVICE EXPERIENCED UNDERFILL OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE TUBE DOES NOT FILL PROPERLY TO THE TOP: THE PATIENT HAD TO BE PRICKED SEVERAL TIMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530288 BD VACUTAINER® CTAD BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1130431

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown