BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 9837162 · Received March 16, 2020

    Report

    Report Number
    1917413-2020-00282
    Event Type
    Malfunction
    Date Received
    March 16, 2020
    Date of Event
    February 21, 2020
    Report Date
    April 22, 2020
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/2/2020. H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SAMPLE QUALITY 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#983913. 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 · 0

    IT WAS REPORTED AFTER USE THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAD POOR BARRIER SEPARATION OF SAMPLE THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHIPPING (REQUIRING AIR TRANSPORT) THE GEL OF THE 3 CPT TUBES SHIFTED. GEL MOVED UP THE SIDE OF THE GLASS TUBE, AND CREATED BUBBLES AND BLEBS".

    Additional Manufacturer Narrative · 1

    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 AFTER USE THE BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE HAD POOR BARRIER SEPARATION OF SAMPLE THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHIPPING (REQUIRING AIR TRANSPORT) THE GEL OF THE 3 CPT TUBES SHIFTED. GEL MOVED UP THE SIDE OF THE GLASS TUBE, AND CREATED BUBBLES AND BLEBS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301683 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362761 9178321 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other