BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 12447930 · Received September 9, 2021

    Report

    Report Number
    3014704491-2021-00130
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 12, 2021
    Report Date
    August 30, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020998. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. BD INVESTIGATORS NOTED THAT THE RETURNED VIDEO DISPLAYED A LEAK OCCURRING AT THE CATHETER TUBING. UNFORTUNATELY, WITHOUT THE ABILITY TO REVIEW THE LEAKING DEVICE THE ROOT CAUSE FOR LEAKAGE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IN CT ROOM, A BENT NEEDLE APPEARED AND THE OTHER ONE'S TUBES WAS LEAKING" "IT'S ALREADY BEEN USED ON PATIENTS. AFTER USE, THE PATIENT WAS FOUND TO HAVE A BULGE AT THE INJECTION SITE, IMMEDIATELY STOP USING. THE DEFECTIVE PRODUCT HAS BEEN DISCARDED. NO HIGH-PRESSURE INJECTION WAS INVOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343799 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ 1020998

    Patients

    Seq Age Sex Outcome Treatment
    1