BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE

    MDR report key: 8916038 · Received August 21, 2019

    Report

    Report Number
    1024879-2019-01490
    Event Type
    Malfunction
    Date Received
    August 21, 2019
    Date of Event
    August 5, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPER POP OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 HAS BEEN REPORTED THAT ONE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND WITH THE STOPPER POPPING OUT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: -IT WAS REPORTED STOPPER POPPED OFF. EMAIL VERBIAGE RECEIVED, - "SST (GOLD) TUBE FOR CHEMISTRY TESTING- THE TOP COME OFF DURING DRAWING SAMPLE AND THEY HAVE TO TAKE ANOTHER TUBE TO COMPLETE SAMPLE DRAWING. THIS IS ALSO AN ONGOING ISSUE. SST (GOLD) ¿ LOT# 9042893, EXP: 1/31/2020"

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT ONE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE HAS BEEN FOUND WITH THE STOPPER POPPING OUT DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED STOPPER POPPED OFF. EMAIL VERBIAGE RECEIVED, - "SST (GOLD) TUBE FOR CHEMISTRY TESTING- THE TOP COME OFF DURING DRAWING SAMPLE AND THEY HAVE TO TAKE ANOTHER TUBE TO COMPLETE SAMPLE DRAWING. THIS IS ALSO AN ONGOING ISSUE. SST (GOLD) ¿ LOT# 9042893, EXP: 1/31/2020."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712670 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9042893 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other