BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES

    MDR report key: 9396783 · Received December 2, 2019

    Report

    Report Number
    1917413-2019-02452
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 11, 2019
    Report Date
    January 14, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679640
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPER PULL OUT WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 · 0

    IT WAS REPORTED THAT THE RUBBER STOPPER REMAINED IN THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE DURING R&D TESTING FOR STOPPER REMOVAL FORCES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. CATALOG # BATCH # TEST DATE DATA REVIEW DATE OBSERVATION 367964 9095794 (B)(6)2019 (B)(6)2019 DID NOT MEET MINIMUM FORCE SPECIFICATION 367729 9241023 (B)(6)2019 (B)(6)2019 DID NOT MEET MEAN FORCE SPECIFICATION 367729 9241024 (B)(6)2019 (B)(6)2019 DID NOT MEET MEAN FORCE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    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 THAT THE RUBBER STOPPER REMAINED IN THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARIN (LH) BLOOD COLLECTION TUBE DURING R&D TESTING FOR STOPPER REMOVAL FORCES. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. CATALOG # BATCH # TEST DATE DATA REVIEW DATE OBSERVATION 367964 9095794 11 NOV 2019 13 NOV 2019 DID NOT MEET MINIMUM FORCE SPECIFICATION 367729 9241023 12 NOV 2019 13 NOV 2019 DID NOT MEET MEAN FORCE SPECIFICATION 367729 9241024 12 NOV 2019 13 NOV 2019 DID NOT MEET MEAN FORCE SPECIFICATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193938 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367964 9095794 50382903679640

    Patients

    Seq Age Sex Outcome Treatment
    1 Other