BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CTAD BLOOD COLLECTION TUBES

    MDR report key: 9224788 · Received October 23, 2019

    Report

    Report Number
    9617032-2019-01198
    Event Type
    Malfunction
    Date Received
    October 23, 2019
    Date of Event
    October 8, 2019
    Report Date
    October 14, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991120
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9095602. MEDICAL DEVICE EXPIRATION DATE: 2020-04-30. DEVICE MANUFACTURE DATE: 2019-04-05. MEDICAL DEVICE LOT #: 9081676. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2019-03-22. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO LOW DRAW AS ALL SAMPLES MET SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® CTAD BLOOD COLLECTION TUBE HAD AN INSUFFICIENT VACUUM AND UNDERFILLED DURING USE. LOT #'S 9095602 AND 9081676 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH LOT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DIFFICULTIES TO FILL THE TUBES (INSUFFICIENT VACUUM IN THE TUBE). 1 TO 2 PERCENT OF TUBES REFUSED TO INSUFFICIENT FILL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1024646 BD VACUTAINER® CTAD BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other