BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE W/ SODIUM HEPARIN

    MDR report key: 8992238 · Received September 11, 2019

    Report

    Report Number
    1917413-2019-02052
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 27, 2019
    Report Date
    August 29, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ CELL PREPARATION TUBE W/ SODIUM HEPARIN HAD POOR SEPARATOR MOVEMENT. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 362753, BATCH NO. 9003642. IT WAS REPORTED THAT THE SEPARATION OF CELLS WAS NOT ACHIEVED. I WOULD LIKE TO REPORT ISSUES WITH CPT TUBES CATALOG NO. 362753. WE¿VE DISTRIBUTED THESE TUBES TO SEVERAL SITES AND SOME HAVE REPORTED ISSUES WITH THE PRODUCT NOT WORKING. SPECIFICALLY, THE SEPARATION OF CELLS IS NOT ACHIEVED AS THE ENTIRE WHOLE BLOOD REMAINS ABOVE THE GEL THAT WOULD SEPARATE THEM. THERE ARE 2 LOT #S FOR WHICH THE ISSUE HAS BEEN OBSERVED. THEY ARE: # 9003637 AND #9003642.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783615 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE W/ SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9003642 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other