BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX NRFIT CONNECTOR EPIDURAL MINIPAK

    MDR report key: 21333073 · Received February 7, 2025

    Report

    Report Number
    3011237704-2025-00020
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    November 2, 2024
    Report Date
    February 7, 2025
    Manufacturer
    SMITHS MEDICAL CZECH REPUBLIC A. S
    Product Code
    CAZ
    UDI-DI
    15019517075335
    PMA / PMN Number
    K965017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: COMPONENTS FROM TWO 24-1300-22 NRFIT CONNECTOR, MINIPACK 1, EPIDURAL, 16G TUOHY NDL, CE3E CATH, 10/BX WERE RECEIVED WITHOUT THEIR ORIGINAL PACKAGING FOR INVESTIGATION. CUSTOMER ALSO PROVIDED PHOTOS OF SAMPLE. ON PHOTOS PROVIDED BY CUSTOMER ARE VISIBLE COMPONENTS 30-4498-001 CONNECTOR, CATHETER, 19G-21G, (US) 16G-18G (SMI), ISO 80369-6 AND 30-4451 FILTER, 0.2 MICRON, ISO NEURAXIAL F/M, ROTATING HUB. ON THE SECOND PHOTO THE YELLOW ROTATING COLLAR IS DETACHED FROM FILTER. SAMPLES PROVIDED BY CUSTOMER WERE VISUALLY INSPECTED WITH NO PROBLEM FOUND, SO BOTH OF THE SAMPLES WERE TESTED BY CONNECTING THE FILTER WITH THE CONNECTOR AND THEN SLIGHTLY PULLED TO SEE IF THE FILTER WILL DETACH OR NOT. ON FIRST VIDEO YOU CAN SEE THAT THE TESTED SAMPLE IS CONNECTED SUCCESSFULLY AND THEN AFTER PULLING THE COMPONENTS DID NOT DETACH. ON SECOND VIDEO, YOU CAN SEE THAT DURING THE CONNECTION OF FILTER AND CONNECTOR, THE YELLOW ROTATING COLLAR DETACHED FROM FILTER. THIS WAS PROBABLY CAUSED BY PREVIOUS OVERTIGHTENING OF CONNECTION BETWEEN FILTER AND CONNECTOR. AS PER INSTRUCTIONS FOR USE, "OVERTIGHTENING THE CONNECTION BETWEEN THE EPIDURAL CATHETER CONNECTOR OR EPIDURAL NEEDLE TO THE MALE ROTATING COLLAR MAY CAUSE ROTATING COLLAR TO DISLODGE FROM FILTER BODY". BASED ON THE EVENT DESCRIPTION AND SAMPLES CONDITION THE DISCONNECTION WAS PROBABLY CAUSED WHEN THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. NO TREND OF SIMILAR CUSTOMER COMPLAINTS HAS BEEN IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CONNECTION BETWEEN THE CATHETER AND FILTER DISCONNECTED WHEN IT WAS BEING ATTACHED. WHEN THE USER CONNECTED THE CATHETER TO THE FILTER, SHE SCREWED IT ON. WHEN SHE DID THAT, THE YELLOW TOP MADE A POP SOUND, AND IT THEN VERY EASILY DISCONNECTED FROM THE FILTER. THE ANESTHETIST HAD 3 CATHETERS WITH THE SAME ISSUE ALL FROM BATCH#: 4461203. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298011 PORTEX NRFIT CONNECTOR EPIDURAL MINIPAK ANESTHESIA CONDUCTION KIT CAZ SMITHS MEDICAL CZECH REPUBLIC A. S 4461203 15019517075335

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female