BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 10698190 · Received October 19, 2020

    Report

    Report Number
    1024879-2020-00716
    Event Type
    Malfunction
    Date Received
    October 19, 2020
    Date of Event
    September 25, 2020
    Report Date
    November 13, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. THEREFORE, TUBES FROM BD MANUFACTURING LINE WERE EVALUATED DURING IN-PROCESS TESTING AND THE ISSUE RELATING TO STOPPER POP OFF WAS OBSERVED. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES 4 STOPPERS POPPED OFF AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DURING TESTS WITH AN SST TUBE, I OPENED 10 CAPS AND REINSERTED THEM AS RECOMMENDED BY THE IU, BUT 4 CAPS OPENED AFTER CENTRIFUGATION (3000 RPM / 10 MIN) AND THEN DURING TRANSPORT THEY ALSO OPENED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 0050537 WAS REPORTED, HOWEVER, THIS IS NOT A LOT# MANUFACTURED FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES 4 STOPPERS POPPED OFF AFTER CENTRIFUGATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING TESTS WITH AN SST TUBE, I OPENED 10 CAPS AND REINSERTED THEM AS RECOMMENDED BY THE IU, BUT 4 CAPS OPENED AFTER CENTRIFUGATION (3000 RPM / 10 MIN) AND THEN DURING TRANSPORT THEY ALSO OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167326 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other