BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10954432 · Received December 5, 2020

    Report

    Report Number
    3006948883-2020-00891
    Event Type
    Malfunction
    Date Received
    December 5, 2020
    Date of Event
    October 6, 2020
    Report Date
    December 15, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9233892. 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. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE THE OPERATION OF THYROID NODULE, THE PATIENT WAS EXAMINED BY ENHANCED CT WITH THE INDWELLING NEEDLE. DURING THE PUNCTURE, THE PATIENT'S VEIN CONDITIONS WERE GOOD AND THE PUNCTURE WENT SMOOTHLY. DURING THE FIXATION AFTER THE PUNCTURE, IT WAS FOUND THAT THE Y-TYPE JUNCTION OF THE INDWELLING NEEDLE WAS PERMEATED ALL THE TIME, SO THE PATIENT WAS PULLED OUT, AND THE INDWELLING NEEDLE WAS REPLACED AND THE PUNCTURE SITE WAS CHANGED AGAIN. THERE WERE NO PROBLEMS WITH ENHANCED CT. RE-PUNCTURE ADDS TO THE PATIENT'S PAIN.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: BEFORE THE OPERATION OF THYROID NODULE, THE PATIENT WAS EXAMINED BY ENHANCED CT WITH THE INDWELLING NEEDLE. DURING THE PUNCTURE, THE PATIENT'S VEIN CONDITIONS WERE GOOD AND THE PUNCTURE WENT SMOOTHLY. DURING THE FIXATION AFTER THE PUNCTURE, IT WAS FOUND THAT THE Y-TYPE JUNCTION OF THE INDWELLING NEEDLE WAS PERMEATED ALL THE TIME, SO THE PATIENT WAS PULLED OUT, AND THE INDWELLING NEEDLE WAS REPLACED AND THE PUNCTURE SITE WAS CHANGED AGAIN. THERE WERE NO PROBLEMS WITH ENHANCED CT. RE-PUNCTURE ADDS TO THE PATIENT'S PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1417106 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9233892

    Patients

    Seq Age Sex Outcome Treatment
    1