BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER 9NC 0.109M PLUS BLOOD COLLECTION TUBES

    MDR report key: 10742278 · Received October 27, 2020

    Report

    Report Number
    9617032-2020-00839
    Event Type
    Malfunction
    Date Received
    October 27, 2020
    Date of Event
    September 23, 2020
    Report Date
    December 31, 2020
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903630955
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FOR EVALUATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING VALIDATION WITH 50 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES THERE WERE DISCREPANCIES WITH THE MEASUREMENTS OF THE STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL HAS RECENTLY CARRIED OUT VALIDATION WORK OF THE NEW CITRATE STOPPER FORMULATION AGAINST THE PREVIOUS STOPPER FORMULATION AND HAVE FOUND DISCREPANCIES BETWEEN INR MEASUREMENTS ON THE TWO STOPPER TYPES. THE DIFFERENCE IN INR RESULTS BETWEEN THE TWO STOPPER FORMULATIONS IS INCREASING WITH AN INCREASE IN INR.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0175695, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2020-06-23, MEDICAL DEVICE LOT #: 0160957, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: 2020-06-08. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING VALIDATION WITH 50 BD VACUTAINER® 9NC 0.109M PLUS BLOOD COLLECTION TUBES THERE WERE DISCREPANCIES WITH THE MEASUREMENTS OF THE STOPPERS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HOSPITAL HAS RECENTLY CARRIED OUT VALIDATION WORK OF THE NEW CITRATE STOPPER FORMULATION AGAINST THE PREVIOUS STOPPER FORMULATION AND HAVE FOUND DISCREPANCIES BETWEEN INR MEASUREMENTS ON THE TWO STOPPER TYPES. THE DIFFERENCE IN INR RESULTS BETWEEN THE TWO STOPPER FORMULATIONS IS INCREASING WITH AN INCREASE IN INR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1209694 BD VACUTAINER 9NC 0.109M PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 363095 SEE H.10 50382903630955

    Patients

    Seq Age Sex Outcome Treatment
    1