BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 9356362 · Received November 21, 2019

    Report

    Report Number
    9617032-2019-01327
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 20, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903668828
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO BLOOD POOLING OR SPILLAGE 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 · 0

    IT WAS REPORTED THAT BLOOD POOLING OCCURRED DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BLOOD POOLING IN STOPPER OF SSTII 2,5ML 366882 LOT 9128593 IN COMBO WITH PB UTW 23G 367364. A SSTII 2,5ML 366882 LOT 9128593 SHOWED BLOOD POOLING IN THE HEMOGARD STOPPER WHEN FILLED WITH THE PB UTW 23G 367364 LOT 9011664. THIS TUBE WAS THE 4TH IN THE DRAWN ORDER. UPON MIXING THE TUBE THE BLOOD IN THE STOPPER GETS LOOSE AND FALLS ON THE PATIENT'S CLOTHES, THE NURSE'S APRON AND THE PHLEBOTOMY TROLLEY (SPLATTER). THIS ALREADY HAPPENED BEFORE BUT WAS NOT COMMUNICATED TO BD."

    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 BLOOD POOLING OCCURRED DURING USE WITH A BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BLOOD POOLING IN STOPPER OF SSTII 2,5ML 366882 LOT 9128593 IN COMBO WITH PB UTW 23G 367364. A SSTII 2,5ML 366882 LOT 9128593 SHOWED BLOOD POOLING IN THE HEMOGARD STOPPER WHEN FILLED WITH THE PB UTW 23G 367364 LOT 9011664. THIS TUBE WAS THE 4TH IN THE DRAWN ORDER. UPON MIXING THE TUBE THE BLOOD IN THE STOPPER GETS LOOSE AND FALLS ON THE PATIENT'S CLOTHES, THE NURSE'S APRON AND THE PHLEBOTOMY TROLLEY (SPLATTER). THIS ALREADY HAPPENED BEFORE BUT WAS NOT COMMUNICATED TO BD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154170 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 9128593 50382903668828

    Patients

    Seq Age Sex Outcome Treatment
    1 Other