BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE SET 15¿M BCV PRIMING CAP 185CM

    MDR report key: 12453017 · Received September 10, 2021

    Report

    Report Number
    2243072-2021-02282
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    August 11, 2021
    Report Date
    October 29, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 9/9/2021. H.6. INVESTIGATION: THREE 03501412321H SAMPLES FROM LOT 20210122 WERE RECEIVED FOR INVESTIGATION; THE SAMPLES WERE ALL RECEIVED IN OPENED PACKAGING AND WITH RESIDUAL FLUID PRESENT IN THE LINE. THE SAMPLES WERE SENT TO THE BD PRODUCT TEST LABORATORY IN ORDER TO PERFORM INFUSIONS AT VARIOUS DIFFERENT INFUSION RATES; IN EACH INSTANCE NO ISSUES WERE OBSERVED WHEN SETTING UP THE INFUSION WITH RATES OF 30, 60, 90 AND 120 DROPS/MIN ACHIEVED. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER, ANHUI TIANKANG MEDICAL PRODUCTS CO. LTD, FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FROM LOT 20210122 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. IT WAS NOT POSSIBLE TO CONFIRM THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE IN THIS INSTANCE. TESTING OF THE RETURNED SAMPLE DID NOT IDENTIFY ANY PRODUCT DEFECTS OR QUALITY DEVIATIONS THAT COULD HAVE CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRESSURE SET 15 M BCV PRIMING CAP 185CM HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THIS INFUSION SYSTEM, THE CONTROLLABILITY IS AS FOLLOWS: WHEEL UP FREE FLOW, SLOW CLOSING, REGULATING DOWN IS ACCOMPANIED BY THE DECREASE OF FLOW RATE".

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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 PRESSURE SET 15M BCV PRIMING CAP 185CM HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN THIS INFUSION SYSTEM, THE CONTROLLABILITY IS AS FOLLOWS: WHEEL UP FREE FLOW, SLOW CLOSING, REGULATING DOWN IS ACCOMPANIED BY THE DECREASE OF FLOW RATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350664 PRESSURE SET 15¿M BCV PRIMING CAP 185CM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 20210122

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown