BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESSURE SET 15¿M BCV PRIMING CAP 185CM

    MDR report key: 12652531 · Received October 18, 2021

    Report

    Report Number
    2243072-2021-02524
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    September 19, 2021
    Report Date
    December 13, 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.4. MEDICAL DEVICE LOT#: 20210303. D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 11/12/2021. H.6. INVESTIGATION: ONE 03501412321H SAMPLE FROM LOT 20210303 WAS RECEIVED IN OPEN PACKAGING FOR INVESTIGATION, THERE WAS NO RESIDUAL FLUID IN THE DEVICE. THERE DID NOT APPEAR TO BE ANY VISUAL OR FUNCTIONAL ISSUES WITH THE ROLLER CLAMP. 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. FURTHERMORE THE INFUSIONS WERE NOTED TO COMPLETE WITHIN THE EXPECTED ACCURACIES FOR AN ADMINISTRATION SET UTILISING GRAVITY FLOW. 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 20210303 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. PLEASE NOTE, GRAVITY INFUSIONS SHOULD ALWAYS BE CLOSELY MONITORED BY THE USER AND SHOULD NOT BE USED AS STANDARD PRACTICE FOR CRITICAL INFUSIONS. IF IT IS CLINICALLY RELEVANT TO CONTROL SHORT-TERM RATE ACCURACY OF THE INFUSION A PUMP SHOULD BE RECOMMENDED. AS WITH ALL INFUSIONS UTILISING GRAVITY FLOW IT IS RECOMMENDED THAT THE RATE SHOULD BE VERIFIED SHORTLY AFTER SET-UP AND THEN AT REGULAR INTERVALS AFTERWARDS. THE FACTORS THAT INFLUENCE FLOW CONTROL ALSO INCLUDE: THE CONDITION AND SIZE OF THE VEIN, THE GAUGE SIZE AND LENGTH OF THE CATHETER, THE TYPE AND VISCOSITY OF THE FLUID, THE TEMPERATURE OF THE FLUID, THE HEIGHT OF THE CONTAINER, OTHER INLINE DEVICES AND THE POSITION OF THE DEVICE WITHIN THE VEIN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRESSURE SET 15M BCV PRIMING CAP 185CM WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿DURING THE PREPARATION OF THE INFUSION THE LIQUID DOES NOT FLOW THROUGH THE SYSTEM.¿

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 15 M BCV PRIMING CAP 185CM WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿DURING THE PREPARATION OF THE INFUSION THE LIQUID DOES NOT FLOW THROUGH THE SYSTEM.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1546351 PRESSURE SET 15¿M BCV PRIMING CAP 185CM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON 20210303

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown