BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX NR FIT EPIDURAL CONTINUOUS TRAY

    MDR report key: 20495257 · Received October 21, 2024

    Report

    Report Number
    3012307300-2024-11541
    Event Type
    Malfunction
    Date Received
    October 21, 2024
    Date of Event
    September 1, 2024
    Report Date
    October 21, 2024
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    BSO
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: MONTH AND YEAR OF EVENT HAVE BEEN PROVIDED; DAY IS UNKNOWN. USED SAMPLES (EPIFUSE CONNECTOR/ FLAT FILTER / FILTER COVER / EPIDURAL CATHETER) WERE RETURNED. ITEM # KIT: NCE6688JP /COMPONENT (CATHETER): 007/377/418 LOT # KIT : 240515 / COMPONENT(CATHETER): 4435942 UPON INSPECTION, THE CATHETER WAS FOUND TO HAVE STRETCHED OVER A LENGTH OF APPROXIMATELY 12 CM FROM THE END. THE LENGTH OF THE CATHETER WAS MEASURED AND FOUND TO BE ONLY APPROXIMATELY 72.5 CM. THE FRACTURE SURFACE WAS LEMON-SHAPED AND SHOWED TRACES OF HAVING BEEN CUT WITH SCISSORS. THE REPORTED EVENT WAS CONFIRMED. AS A RESULT OF THE INVESTIGATION, IT WAS DETERMINED THAT THE CAUSE OF THIS EVENT WAS THE SCISSORS COMING INTO CONTACT WITH THE CATHETER WHILE THE PRODUCT WAS BEING USED. REVIEW OF MANUFACTURING RECORDS, RELEVANT TO THE LOT RECEIVED, FOUND NO DISCREPANCIES OR ANOMALIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER RUPTURED. THIS OCCURRED DURING USE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1930967 PORTEX NR FIT EPIDURAL CONTINUOUS TRAY CATHETER, CONDUCTION, ANESTHETIC BSO SMITHS MEDICAL ASD, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown