BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8692785 · Received June 12, 2019

    Report

    Report Number
    3006948883-2019-00456
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 22, 2019
    Report Date
    August 28, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023837. 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. ADDITIONALLY BASED AN ANALYSIS OF THE EVENT DESCRIPTION YOUR FACILITY HAS PROVIDED, OUR ENGINEERS DETERMINED, THROUGH A REVIEW OF RELEVANT LITERATURE, THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS A CHEMICAL REACTION BETWEEN REDOUNDING AND CEPHALOSPORIN CAN RESULT IN PRECIPITATE FORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM SEDIMENT WAS FOUND IN THE TUBING. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: A TWO-YEAR-OLD PATIENT WAS HOSPITALIZED WITH FEBRILE CONVULSIONS. THE DOCTOR PRESCRIBED DIAZEPAM INJECTION INTRAVENOUSLY AND THEN TRANSFUSED THE SOLUTION. SEDIMENT WAS FOUND IN THE TUBING BEFORE THE NEXT DAY'S TRANSFUSION. 2019-05-27 LOT# 383028 UPDATE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM SEDIMENT WAS FOUND IN THE TUBING. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: A TWO-YEAR-OLD PATIENT WAS HOSPITALIZED WITH FEBRILE CONVULSIONS. THE DOCTOR PRESCRIBED DIAZEPAM INJECTION INTRAVENOUSLY AND THEN TRANSFUSED THE SOLUTION. SEDIMENT WAS FOUND IN THE TUBING BEFORE THE NEXT DAY'S TRANSFUSION. 2019-05-27 LOT# 383028 UPDATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487153 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9023837 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Other