BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE

    MDR report key: 9437561 · Received December 9, 2019

    Report

    Report Number
    9617032-2019-01409
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 21, 2019
    Report Date
    January 17, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630481
    PMA / PMN Number
    K013971
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR OVERFILL WITH THE INCIDENT LOT WAS NOT OBSERVED, THE PHOTO SHOWS THE DRAWN TUBE WITH ACCEPTABLE MAXIMUM FILL LEVEL. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO OVERFILL AS ALL SAMPLES MET SPECIFICATIONS. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF OVERFILL LEADING TO LOOSE CLOSURES AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PHLEBOTOMY STAFF HAVE IDENTIFIED A PROBLEM WITH A BATCH OF CITRATE BOTTLES FOR COAGULATION TESTING. BOTTLES ARE OVERFILLING AND CAUSING THE TOP TO BECOME LOOSE. A SMALL COMPARISON STUDY HAS BEEN CARRIED OUT WITH THE ¿FAULTY¿ BOTTLES AND THE BOTTLES IN CURRENT USE (WHICH ARE OK) AND THE RESULTS ARE COMPARABLE SO ANY RESULTS THAT MAY HAVE GONE OUT ON THESE BOTTLES.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: 9210381 WAS REPORTED BUT IS NOT VALID FOR THIS PRODUCT. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE HAS BEEN FOUND EXPERIENCING FIVE OCCURRENCES OF OVERFILL LEADING TO LOOSE CLOSURES AFTER USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: PHLEBOTOMY STAFF HAVE IDENTIFIED A PROBLEM WITH A BATCH OF CITRATE BOTTLES FOR COAGULATION TESTING. BOTTLES ARE OVERFILLING AND CAUSING THE TOP TO BECOME LOOSE. A SMALL COMPARISON STUDY HAS BEEN CARRIED OUT WITH THE ¿FAULTY¿ BOTTLES AND THE BOTTLES IN CURRENT USE (WHICH ARE OK) AND THE RESULTS ARE COMPARABLE SO ANY RESULTS THAT MAY HAVE GONE OUT ON THESE BOTTLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237047 BD VACUTAINER® 9NC 0.109M BUFFERED TRISODIUM CITRATE PLUS BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363048 9210381 50382903630481

    Patients

    Seq Age Sex Outcome Treatment
    1 Other