BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX ULTRAPERC DILATOR KIT

    MDR report key: 13552687 · Received February 17, 2022

    Report

    Report Number
    3012307300-2022-03594
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Date of Event
    January 17, 2022
    Report Date
    October 18, 2022
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    KCG
    UDI-DI
    55019517103418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. IT WAS DETERMINED THAT IT WAS A SUPPLIED ITEMS FAULT. DHR REVIEW WAS DONE, NO ISSUES RELATED TO THE ORIGINAL COMPLAINT WERE FOUND.

    Additional Manufacturer Narrative · 0

    OTHER TEXT: G3: JAPAN. DEVICE EVALUATION: ONE DEVICE WAS RETURNED FOR ANALYSIS IN USED CONDITION. SAMPLE WAS RECEIVED USED AND DECONTAMINATED. VISUAL INSPECTION SHOWED THE LINE WAS DETACHED FROM THE PILOT BALLOON. THE RETURNED DEVICE HAD LOT NUMBER 4064204 LASER PRINTED ON ITS FLANGE. A DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO OBSERVATIONS RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCT., CORRECTED DATA: UPDATED: D3, D4 UDI, G2. H6 PATIENT CODE ONLY 4582, UPDATE EVALUATION CODES: RESULT AND CONCLUSION. H10 CORRECTED DEVICE ANALYSIS, COUNTRY PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER THE PRODUCT WAS INDWELLED, THE INFLATION LINE GOT DETACHED. NO PATIENT INJURY WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE FOR THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604230 PORTEX ULTRAPERC DILATOR KIT DILATOR, TRACHEAL KCG SMITHS MEDICAL ASD, INC. 55019517103418

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown