BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CO

    MDR report key: 14311621 · Received May 6, 2022

    Report

    Report Number
    3012307300-2022-07865
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 1, 2020
    Report Date
    June 8, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    PWH
    UDI-DI
    10610586044014
    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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED SUBSEQUENT TO THE MANUFACTURING OF THE DEVICE AND PRIOR TO ITS RELEASE. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. SYRINGE PART THAT REMAINED IN THE LUER WAS FOUND. LUER WAS MEASURED TO ENSURE THE INNER DIAMETER IS WITHIN SPECIFICATION. NO ANOMALIES WERE FOUND; INNER DIAMETER IS WITHIN SPECIFICATION. A REVIEW OF THE MANUFACTURING PROCESS FOR WAS CONDUCTED BY QUALITY ENGINEER IN ORDER TO VERIFY THAT THERE ARE NO SITUATIONS OR PRACTICES THAT COULD CREATE THE EVENT. NO DISCREPANCIES WERE FOUND. NO ROOT CAUSE HAS TO BE DETERMINED SINCE NO ANOMALIES WERE FOUND IN THE SAMPLE RECEIVED FOR EVALUATION. NO CORRECTIVE ACTIONS ARE REQUIRED SINCE THE COMPLAINT WAS NOT CONFIRMED. A NOTIFICATION OF THE REPORTED FAILURE MODE TO THE PRODUCTION PERSONNEL WAS CONDUCTED BY THE QUALITY ENGINEER.

    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. REPORT 3012307300-2022-07865 IS NO LONGER CONSIDERED REPORTABLE, PLEASE DISREGARD ANY MDR REPORTS ASSOCIATED WITH IT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN THE CUSTOMER WAS FILLING UP MEDICAL FLUID INTO THE CASSETTE, THE SYRINGE TIP BROKE OFF AND THE BROKEN PART REMAINED IN THE CONNECTION PART OF THE OF THE TUBE. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079239 CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT CO ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS PWH SMITHS MEDICAL ASD, INC. 21-7609-24 3883725 10610586044014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown