BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE

    MDR report key: 12961937 · Received December 8, 2021

    Report

    Report Number
    1917413-2021-01041
    Event Type
    Malfunction
    Date Received
    December 8, 2021
    Date of Event
    November 10, 2021
    Report Date
    November 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903679619
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1040990. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2021-02-09. MEDICAL DEVICE LOT #: 1137429. MEDICAL DEVICE EXPIRATION DATE: DEVICE MANUFACTURE DATE: 2021-05-17. MEDICAL DEVICE LOT #: 1195879 . MEDICAL DEVICE EXPIRATION DATE: 2022-05-31. DEVICE MANUFACTURE DATE: 2021-07-14. MEDICAL DEVICE LOT #: 1123998. MEDICAL DEVICE EXPIRATION DATE: 2022-04-30. DEVICE MANUFACTURE DATE: 2021-05-03. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR UNDERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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 UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED UNDERFILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: WE DISCOVERED THAT SOME OF OUR 3.5ML LITHIUM HEPARIN TUBES ARE NOT FILLING COMPLETELY WHICH IS AN ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861515 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) 65 UNITS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367961 SEE H.10. 50382903679619

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown