BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9812214 · Received March 10, 2020

    Report

    Report Number
    1024879-2020-00183
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    February 18, 2020
    Report Date
    May 1, 2020
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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. ALL STOPPERS REMAINED FULLY ON THE TUBES AFTER DRAW TESTING. 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 AFTER USE THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD THE STOPPER CREEP OUT OR LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOPS OF THE TUBES POPPING OFF AND APPEAR TO BE LOOSE".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9319578. MEDICAL DEVICE EXPIRATION DATE: 2020-11-30. DEVICE MANUFACTURE DATE: 2019-11-15. MEDICAL DEVICE LOT #: 9081742. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9255653. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2019-09-12. 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 AFTER USE THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD THE STOPPER CREEP OUT OR LOOSE CLOSURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TOPS OF THE TUBES POPPING OFF AND APPEAR TO BE LOOSE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277489 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