BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NRFIT CADD ADMINISTRATION SETS - FLOW STOP

    MDR report key: 14309923 · Received May 6, 2022

    Report

    Report Number
    3012307300-2022-07809
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    February 1, 2021
    Report Date
    May 24, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    PWH
    UDI-DI
    10610586044748
    PMA / PMN Number
    K162219
    Removal / Correction Number
    Z-0148-2022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    NO LOT NUMBER WAS PROVIDED; THEREFORE, DEVICE HISTORY RECORD REVIEW COULD NOT BE COMPLETED. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE SAMPLES RETURNED WERE TESTED USING THE HYDROSTATIC VESSEL. A LEAK WAS DETECTED FLEEING FROM THE JOINT OF THE PUMP TUBE AND "TUBE 105". THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT WAS FOUND TO BE LACK/INSUFFICIENT CYCLOHEXANONE ADHESIVE".

    Additional Manufacturer Narrative · 0

    WHILE PERFORMING A REVIEW OF SUBMITTED MDR REPORT IT WAS DISCOVERED THAT THIS FILE WAS INADVERTENTLY ASSESSED AS REPORTABLE. NO PATIENT DEATH, SERIOUS INJURY, AND NO EVIDENCE OF A REPORTABLE PRODUCT MALFUNCTION. THE HAZARDOUS SITUATION FOR THE GIVEN COMPLAINT DEVICE WOULD NOT LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. FILE (B)(4) IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLUID LEAKED FROM THE CONNECTOR. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1077781 NRFIT CADD ADMINISTRATION SETS - FLOW STOP SET, I.V. FLUID TRANSFER PWH SMITHS MEDICAL ASD, INC. 21-7624-24 10610586044748

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown