BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES

    MDR report key: 12054784 · Received June 23, 2021

    Report

    Report Number
    9617032-2021-00667
    Event Type
    Malfunction
    Date Received
    June 23, 2021
    Date of Event
    June 1, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. TO FURTHER INVESTIGATE, RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED AND UPON COMPLETION, ISSUES RELATING TO GEL GLOBULES WERE OBSERVED. 4 RETAINED SAMPLES FROM EACH LOT NUMBER PROVIDED(LOT 1033165; LOT 0345034; LOT 1069957; LOT 1053924) WERE DRAWN WITH HORSE BLOOD, MIXED, STOOD AT ROOM TEMPERATURE FOR 30 MINUTES, BEFORE BEING CENTRIFUGED AT 3450 RPM FOR 10 MINUTES, USING AN MSE MISTRAL 1000 CENTRIFUGE. THE SUPERNATANTS WERE THEN DECANTED AND EXAMINED UNDER MAGNIFICATION FOR ANY SIGNS OF GEL GLOBULES. 6 (LOT 1033165 AND LOT 0345034) OUT OF 16 TUBES PRODUCED GLOBULES. THIS COMPLAINT WAS ABLE TO BE CONFIRMED FOR GEL GLOBULES FROM THE RETAIN TESTING RESULTS. 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. 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® LH PST¿ II PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OIL GEL GLOBULES AND CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER HAS OBSERVED GEL GLOBULES IN THE PST TUBES. THEY BELIEVE THAT THIS HAS CAUSED CLOTTING IN THE INSTRUMENT PROBES WHICH LEADS TO EXCHANGING THE PROBES.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1033165, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1069957, MEDICAL DEVICE EXPIRATION DATE: 2022-09-30, DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1053924, MEDICAL DEVICE EXPIRATION DATE: 2022-08-31, DEVICE MANUFACTURE DATE:(B)(6) 2021. MEDICAL DEVICE LOT #: 0345034, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: (B)(6) 2020. 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® LH PST¿ II PLUS BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED OIL GEL GLOBULES AND CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: CUSTOMER HAS OBSERVED GEL GLOBULES IN THE PST TUBES. THEY BELIEVE THAT THIS HAS CAUSED CLOTTING IN THE INSTRUMENT PROBES WHICH LEADS TO EXCHANGING THE PROBES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951314 BD VACUTAINER LH PST II PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) SEE. H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1