BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17785423 · Received September 20, 2023

    Report

    Report Number
    3014704491-2023-00571
    Event Type
    Malfunction
    Date Received
    September 20, 2023
    Date of Event
    August 25, 2023
    Report Date
    September 25, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FMI
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3052735. 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. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PHONE #: (B)(6). H3. 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¿ CLOSED IV CATHETER SYSTEM TUBING WAS DAMAGED AND LEAKING. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, THE NURSES IN THE EMERGENCY DEPARTMENT OF OUR HOSPITAL WERE USING THE CLOSED INTRAVENOUS INDWELLING NEEDLE PRODUCED BY BD COMPANY. THE PATIENT WAS SUCCESSFULLY PUNCTURED. DURING INFUSION, FLUID LEAKAGE WAS SEEN AT THE TRANSPARENT CATHETER. AFTER WIPING, THE INSPECTION FOUND THAT THE FLUID WAS STILL LEAKING. IT SHOULD BE THAT THE CATHETER WAS DAMAGED. AFTER THE INFUSION WAS SUSPENDED, THE BD NEEDLE WAS PULLED OUT. NORMAL INFUSION AFTER REPLACEMENT OF A NEW INDWELLING NEEDLE, WHICH AFFECTED THE WORK OF MEDICAL STAFF AND THE TREATMENT OF PATIENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING WAS DAMAGED AND LEAKING. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2023, THE NURSES IN THE EMERGENCY DEPARTMENT OF OUR HOSPITAL WERE USING THE CLOSED INTRAVENOUS INDWELLING NEEDLE PRODUCED BY BD COMPANY. THE PATIENT WAS SUCCESSFULLY PUNCTURED. DURING INFUSION, FLUID LEAKAGE WAS SEEN AT THE TRANSPARENT CATHETER. AFTER WIPING, THE INSPECTION FOUND THAT THE FLUID WAS STILL LEAKING. IT SHOULD BE THAT THE CATHETER WAS DAMAGED. AFTER THE INFUSION WAS SUSPENDED, THE BD NEEDLE WAS PULLED OUT. NORMAL INFUSION AFTER REPLACEMENT OF A NEW INDWELLING NEEDLE, WHICH AFFECTED THE WORK OF MEDICAL STAFF AND THE TREATMENT OF PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2059659 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FMI BD (SUZHOU) 3052735

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown