BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15984177 · Received December 14, 2022

    Report

    Report Number
    3014704491-2022-00658
    Event Type
    Malfunction
    Date Received
    December 14, 2022
    Date of Event
    November 3, 2022
    Report Date
    November 28, 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

    DATE OF BIRTH: ONLY THE PATIENT'S AGE WAS PROVIDED, THEREFORE A DEFAULT DATE OF BIRTH HAS BEEN LISTED INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110889. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE CONNECTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE RESPONSIBLE NURSE IMPLEMENTED INTRAVENOUS INFUSION AND PUNCTURED WITH AN INDWELLING NEEDLE. AFTER THE PUNCTURE WAS SUCCESSFUL, NORMAL SALINE WAS INJECTED, AND FLUID LEAKED FROM THE Y-PORT JOINT. THAT IS, DO A GOOD JOB OF EXPLAINING TO THE FAMILY MEMBERS, PULL OUT THE INDWELLING NEEDLE, REPLACE THE INDWELLING NEEDLE AND RE-PUNCTURE. COMFORT THE PATIENT, AND THE FAMILY MEMBERS OF THE PATIENT EXPRESS THEIR UNDERSTANDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2570951 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110889

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Unknown