BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 9355164 · Received November 21, 2019

    Report

    Report Number
    1917413-2019-02376
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    November 4, 2019
    Report Date
    December 20, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627610
    PMA / PMN Number
    K911731
    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 HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED.

    Description of Event or Problem · 0

    MATERIAL NO: 362761 BATCH NO: 9003647. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE CPT TUBE BROKE DURING A CENTRIFUGATION STUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN FRANKLIN LAKES, WE OBSERVED A CPT TUBE THAT BROKE DURING A CENTRIFUGATION STUDY. THE PRODUCT INFORMATION IS:

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO: 362761, BATCH NO: 9003647. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE THE CPT TUBE BROKE DURING A CENTRIFUGATION STUDY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN (B)(4), WE OBSERVED A CPT TUBE THAT BROKE DURING A CENTRIFUGATION STUDY. THE PRODUCT INFORMATION IS:...

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154118 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9003647 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other