BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 15658102 · Received October 24, 2022

    Report

    Report Number
    3014704491-2022-00506
    Event Type
    Malfunction
    Date Received
    October 24, 2022
    Date of Event
    September 4, 2022
    Report Date
    October 31, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110983. 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. BASED ON YOUR DESCRIPTION OF THE EVENT, OUR ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS.

    Additional Manufacturer Narrative · 0

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: AN INDWELLING NEEDLE WAS PLACED BEFORE ENHANCED CT EXAMINATION OF THE PATIENT. AFTER SUCCESSFUL PUNCTURE, SEVERE WATER LEAKAGE WAS FOUND IN THE PIPELINE DURING SALINE INJECTION, WHICH MADE IT UNUSABLE. THE USE WAS STOPPED IMMEDIATELY, AND THE INDWELLING NEEDLE WAS RE-PLACED ON THE PATIENT AFTER REMOVAL, WITHOUT CAUSING OTHER HARM TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA II¿ IV CATHETER PRN ADAPTER EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: AN INDWELLING NEEDLE WAS PLACED BEFORE ENHANCED CT EXAMINATION OF THE PATIENT. AFTER SUCCESSFUL PUNCTURE, SEVERE WATER LEAKAGE WAS FOUND IN THE PIPELINE DURING SALINE INJECTION, WHICH MADE IT UNUSABLE. THE USE WAS STOPPED IMMEDIATELY, AND THE INDWELLING NEEDLE WAS RE-PLACED ON THE PATIENT AFTER REMOVAL, WITHOUT CAUSING OTHER HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821589 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110983

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown