BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9376757 · Received November 26, 2019

    Report

    Report Number
    1024879-2019-02046
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    November 11, 2019
    Report Date
    December 11, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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 BEFORE USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THERE WERE ISSUES WITH FOREIGN MATTER IN THE GEL, DEFORMED TUBE, DEFECTIVE MARKINGS, DIRTY SHIELD, BLACK SPOTS, GEL AIR BUBBLES, AND AIR BUBBLES IN GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: FM IN GEL X33, DEFORMED TUBE X1, DEFECTIVE MARKING X3, DIRTY SHIELD X1, BLACK SPOTS X2, GEL AIR BUBBLES X102, AIR BUBBLES IN GEL X1.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES THERE WERE ISSUES WITH FOREIGN MATTER IN THE GEL, DEFORMED TUBE, DEFECTIVE MARKINGS, DIRTY SHIELD, BLACK SPOTS, GEL AIR BUBBLES, AND AIR BUBBLES IN GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: FM IN GEL X33. DEFORMED TUBE X1. DEFECTIVE MARKING X3. DIRTY SHIELD X1. BLACK SPOTS X2. GEL AIR BUBBLES X102. AIR BUBBLES IN GEL X1.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174949 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9228649

    Patients

    Seq Age Sex Outcome Treatment
    1 Other