BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES

    MDR report key: 12729254 · Received November 1, 2021

    Report

    Report Number
    9617032-2021-01106
    Event Type
    Malfunction
    Date Received
    November 1, 2021
    Date of Event
    September 27, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES FOR INVESTIGATION. SAMPLES WERE SENT BY THE CUSTOMER AND UNFORTUNATELY WENT MISSING IN TRANSIT. IF THE SAMPLES ARE RECEIVED AT A LATER DATE THE COMPLAINT WILL BE RE-OPENED AND THE INVESTIGATION UPDATED. FOUR (4) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WAS OBSERVED. ADDITIONALLY, TWENTY (20) RETENTION SAMPLES FROM EACH BATCH NUMBER (0146727, 9347844, 0356316, 0041620, 9336072, 0275808) FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE ISSUE OF UNDERFILL WAS NOT OBSERVED. 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 NOTIFICATIONS. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF UNDERFILL BASED ON THE PROVIDED PHOTOS; HOWEVER, RETAINED SAMPLE TESTING WAS SATISFACTORY. 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® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED A TOTAL OF 36 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "QC LAB MANAGER HAS SEEN THAT THE TUBES ARE NOT DRAWING A TOTAL VOLUME OF 10ML. THE TUBES DOES NOT FILL MORE THAT A TOTAL VOLUME OF MAX 8.5ML - 9ML.".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT UMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0146727. MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2020-05-25. MEDICAL DEVICE LOT #: 9347844. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2019-12-13. MEDICAL DEVICE LOT #: 0356316. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2020-12-21. MEDICAL DEVICE LOT #: 0041620. MEDICAL DEVICE EXPIRATION DATE: 2022-01-31. DEVICE MANUFACTURE DATE: 2020-02-10. MEDICAL DEVICE LOT #: 9336072. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2019-12-02. MEDICAL DEVICE LOT #: 0275808. MEDICAL DEVICE EXPIRATION DATE: 2022-10-31. DEVICE MANUFACTURE DATE: 2020-10-01. . 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® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBE THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THIS EVENT OCCURRED A TOTAL OF 36 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "QC LAB MANAGER HAS SEEN THAT THE TUBES ARE NOT DRAWING A TOTAL VOLUME OF 10ML. THE TUBES DOES NOT FILL MORE THAT A TOTAL VOLUME OF MAX 8.5ML - 9ML."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625848 BD VACUTAINER® CAT (CLOT ACTIVATOR TUBE) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown