BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9186143 · Received October 14, 2019

    Report

    Report Number
    1024879-2019-01794
    Event Type
    Malfunction
    Date Received
    October 14, 2019
    Date of Event
    September 24, 2019
    Report Date
    November 6, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679886
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE SHATTERED WHEN THE STOPPER WAS REMOVED. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988, BATCH NO. 9191906. IT WAS REPORTED THAT THE TUBE SHATTERED WHEN THE STOPPER WAS REMOVED. 1 OF 2: BROKEN TUBE. THE STOPPER WAS REMOVED AND THE TUBE SHATTERED. DATE OF EVENT (B)(6) 2019. PATIENT NUMBER: UNKNOWN. THERE IS A BARBED ON THE SIDE OF THE TUBE.

    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 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBE SHATTERED WHEN THE STOPPER WAS REMOVED. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367988. BATCH NO. 9191906. IT WAS REPORTED THAT THE TUBE SHATTERED WHEN THE STOPPER WAS REMOVED. 1 OF 2: BROKEN TUBE. THE STOPPER WAS REMOVED AND THE TUBE SHATTERED. DATE OF EVENT: (B)(6) 2019. PATIENT NUMBER: UNKNOWN. THERE IS A BARBED ON THE SIDE OF THE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983321 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9191906 50382903679886

    Patients

    Seq Age Sex Outcome Treatment
    1 Other