BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 8975335 · Received September 9, 2019

    Report

    Report Number
    1917413-2019-02034
    Event Type
    Malfunction
    Date Received
    September 9, 2019
    Date of Event
    August 15, 2019
    Report Date
    August 23, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627603
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR GEL SMEARING WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 · 1

    IT WAS REPORTED THAT BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAS POOR BARRIER SEPARATION. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 362760, BATCH NO. 8269742. IT WAS REPORTED THAT YOU HAVE BEEN EXPERIENCING ISSUES WITH THE GEL DETACHING FROM THE WALL. THERE HAVE BEEN ISSUES WITH THE GEL DETACHING FROM THE WALL. SITE RECEIVES HUMAN BLOOD COLLECTED IN CPT TUBES. THE TUBES ARE SHIPPED UNSPUN (SHE REPORTS THEY ALSO HAD ISSUES WITH TUBES AND THERE MAY BE AN INVESTIGATION FROM THEM, PR 1123668). THEY WERE NOT ABLE TO ISOLATE CELLS AND THEY CENTRIFUGED THE SAMPLE TWICE. THIS ONLY HAPPENED WITH 1 TUBE. NO OTHER CPT TUBE WAS DRAWN ON THE SAME PATIENT. SHE DID NOT HAVE ANY ADDITIONAL INFORMATION AS SHE IS NOT THE ONE WHO COLLECTS OR PROCESSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768425 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8269742 50382903627603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other