BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9250807 · Received October 29, 2019

    Report

    Report Number
    1024879-2019-01864
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    October 14, 2019
    Report Date
    December 10, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPER PULLOUT WITH THE INCIDENT LOT WAS OBSERVED. 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 11 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED STOPPER CREEP OUT OR LOOSE CLOSURE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367986, BATCH NO: 9213407. LOT NUMBER 9213407, CATALOG NUMBER 367986, 13X100 5.0 ML SST TUBE. FAILED TO MEET MINIMUM SECOND PULLOUT OF 0.7 LBS OR GREATER. QA FINAL INSPECTION FOR EVACUATED TUBES SPECIFICATION. THERE WERE 11/30 FAILURES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THAT 11 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED STOPPER CREEP OUT OR LOOSE CLOSURE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 367986, BATCH NO: 9213407. LOT NUMBER 9213407, CATALOG NUMBER 367986, 13X100 5.0 ML SST TUBE. FAILED TO MEET MINIMUM SECOND PULLOUT OF 0.7 LBS OR GREATER -QA FINAL INSPECTION FOR EVACUATED TUBES SPECIFICATION. THERE WERE 11/30 FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047995 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 9213407 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other