BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® CPT¿ NH: 132 USP UNITS FICOLL¿: 2.0ML

    MDR report key: 8258739 · Received January 17, 2019

    Report

    Report Number
    1917413-2019-00002
    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 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-CONFORMANCE'S 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¿ NH: 132 USP UNITS FICOLL¿: 2.0ML WAS PRODUCED 10 FOLD DECREASE IN YIELD COMPARED TO THE TUBE PROCESSED WITH FITCOLL. PATIENT NEEDED A LAB REDRAW.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. 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 THAT A BD VACUTAINER® CPT¿ NH: 132 USP UNITS FICOLL¿: 2.0ML WAS PRODUCED 10 FOLD DECREASE IN YIELD COMPARED TO THE TUBE PROCESSED WITH FITCOLL. PATIENT NEEDED A LAB REDRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52445 BD VACUTAINER® CPT¿ NH: 132 USP UNITS FICOLL¿: 2.0ML EVACUATED BLOOD COLLECTION TUBE IVD JKA BECTON, DICKINSON & CO. 8213831 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention