BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CADD INFUSION DISP PORTFOLIO WITH NRFIT CONNECTORS

    MDR report key: 12096763 · Received June 30, 2021

    Report

    Report Number
    3012307300-2021-06725
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Report Date
    May 1, 2023
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    PWH
    UDI-DI
    10610586044014
    PMA / PMN Number
    K162219
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER TEXT: ADDITIONAL INFORMATION H6, H10 . THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4) AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. ONE SAMPLE WAS RECEIVED WITHOUT THE ORIGINAL PACKAGING, IN USED CONDITION, DECONTAMINATED AND INSIDE IN A PLASTIC BAG. VISUAL INSPECTION WAS PERFORMED AT 12 TO 16 INCHES UNDER NORMAL CONDITIONS OF ILLUMINATION. VISUAL INSPECTION DID NOT PRESENT ANY DAMAGE, SCUFFS, PINCH MARKS, CRACKS, CRAZING, CUTS, ETC. THAT COULD CAUSE THE FAILURE MODE REPORTED. DURING THE FUNCTIONAL TESTING THE SAMPLE WAS FILLED WITH COLORED WATER USING A SYRINGE TO DETECT ANY LEAKAGE. THE TEST CONFIRMED A LEAKAGE NEAR THE NECK OF THE BAG. THE ROOT CAUSE WAS RELATED TO THE MANUFACTURING PROCESS. ACTION TAKEN INCLUDED UPDATING THE PROCEDURE TO PROVIDE ADEQUATE FLOW IN THE EXECUTION OF THE MANUFACTURING ACTIVITIES., CORRECTED DATA: D1, D2.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT DURING USE OF THIS SMITHS MEDICAL CADD CASSETTE RESERVOIRS LEAKAGE OF MEDICAL FLUID WAS NOTICED. IT WAS REPORTED THAT AFTER FINISHING THE USE OF THE PRODUCT, THE CUSTOMER FOUND LEAKAGE OF MEDICAL FLUID AND NOTICED NO AMOUNT OF MEDICAL FLUID WAS ADMINISTERED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988759 CADD INFUSION DISP PORTFOLIO WITH NRFIT CONNECTORS ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS PWH SMITHS MEDICAL ASD, INC. 21-7609-24 10610586044014
    988766 CADD INFUSION DISP PORTFOLIO WITH NRFIT CONNECTORS ADMINISTRATIONS SETS WITH NEURAXIAL CONNECTORS PWH SMITHS MEDICAL ASD, INC. 21-7609-24 10610586044014

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown