BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES

    MDR report key: 8464831 · Received March 29, 2019

    Report

    Report Number
    1917413-2019-01071
    Event Type
    Malfunction
    Date Received
    March 29, 2019
    Date of Event
    February 27, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903630801
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION AND TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND OVERFILL WAS OBSERVED. THE +10% IS AT 1.98, ONE DREW 1.9884. PER STABILITY ASSESSMENT OF 1.8 ML VACATIONER SAFETY COAGULATION TNT TUBES A SMALL PERCENTAGE OF 1.8 MAY DRAW ABOVE +10% SPECIFICATION UP TO 4 MONTHS PAST DATE OF MANUFACTURE, THEREFORE 1.9884 WAS STILL WITHIN HISTORICAL PRODUCT PERFORMANCE BOUNDARIES. ALL TUBES WERE VISUALLY INSPECTED AND NO DEFECTS WERE FOUND. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND TESTING AND UPON COMPLETION, THE ISSUE RELATING TO OVERFILL WAS NOT 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION AND TESTING OF THE RETAIN SAMPLES WAS ALSO CONDUCTED AND OVERFILL WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED, FURTHER INVESTIGATION DETERMINED HISTORICAL PRODUCT PERFORMANCE BOUNDARIES WERE MET. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WERE OVERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 363080, BATCH NO. 9002613. IT WAS REPORTED THAT THERE WERE SEVERAL INSTANCES OF THE CITRATE TUBE OVERFILLING. SEVERAL INSTANCES OF THE CITRATE TUBE OVERFILLING."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES WERE OVERFILLING. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿MATERIAL NO. 363080 BATCH NO. 9002613. IT WAS REPORTED THAT THERE WERE SEVERAL INSTANCES OF THE CITRATE TUBE OVERFILLING. SEVERAL INSTANCES OF THE CITRATE TUBE OVERFILLING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260313 BD VACUTAINER® 9NC 0.129M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 9002613 50382903630801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other