BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE

    MDR report key: 15238051 · Received August 16, 2022

    Report

    Report Number
    9617032-2022-00771
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    July 2, 2022
    Report Date
    September 1, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903679558
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: H.10 IMDRF ANNEX A GRID: (B)(4). H.6. INVESTIGATION SUMMARY: MATERIAL #: 367955 LOT/BATCH #:1253845 BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TEN (10 )RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO TUBE PUSH OFF OR STOPPER POP OFF, 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 MODES, TUBE PUSH OFF OR STOPPER POP OFF. 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® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IN THE PROCESS OF BLOOD COLLECTION, FINE BUBBLES ARE GENERATED IN THE TUBE, THE PRESSURE RISES, THE NEEDLE IS WITHDRAWN, THE BD SAFETY COVER POPS OUT, AND THE BUBBLES IN THE TUBE OVERFLOW. WFI TASK: IS THE BD SAFETY COVER THE STOPPER? STOPPER. IS ANYONE EXPOSED TO THE BUBBLES OVERFLOWING? YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE THERE WAS STOPPER POPS OUT OF THE TUBE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IN THE PROCESS OF BLOOD COLLECTION, FINE BUBBLES ARE GENERATED IN THE TUBE, THE PRESSURE RISES, THE NEEDLE IS WITHDRAWN, THE BD SAFETY COVER POPS OUT, AND THE BUBBLES IN THE TUBE OVERFLOW. WFI TASK: IS THE BD SAFETY COVER THE STOPPER? -STOPPER. IS ANYONE EXPOSED TO THE BUBBLES OVERFLOWING? -YES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1239035 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367955 1253845 50382903679558

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown