BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 8257071 · Received January 17, 2019

    Report

    Report Number
    1917413-2019-00004
    Event Type
    Injury
    Date Received
    January 17, 2019
    Date of Event
    January 2, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. 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#1092363. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#1092363. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: CAPA#1092363 HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN GAVE ERRONEOUS RESULTS BY SHOWING LOW NUMBERS FOR FICOLL PROCESSING. THE PATIENT HAD TO BE REDRAWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN GAVE ERRONEOUS RESULTS BY SHOWING LOW NUMBERS FOR FICOLL PROCESSING. THE PATIENT HAD TO BE REDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49013 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. 8213831 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention