BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8479082 · Received April 3, 2019

    Report

    Report Number
    3006948883-2019-00240
    Event Type
    Malfunction
    Date Received
    April 3, 2019
    Date of Event
    March 13, 2019
    Report Date
    May 9, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    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 · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171162. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF A 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. BASED ON THE SAMPLE SUBMITTED, BD ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS ISSUE IS AN ANOMALY IN THE FABRICATION PROCESS OF THE RAW MATERIAL USED FOR THE CATHETER TUBING. THE ABRASIVE MARKINGS FOUND ON THE DEVICE OCCUR SPORADICALLY DURING THE EXTRUDING PROCESS AND ARE CONTROLLED THROUGH VISUAL SORTING OF THE MATERIAL DURING RECEIPT FROM THE SUPPLIER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE ADAPTER WHILE PREPARING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "IT WAS FOUND LIQUID LEAKAGE AT ADAPTOR DURING PREPARATION."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED FROM THE ADAPTER WHILE PREPARING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT WAS FOUND LIQUID LEAKAGE AT ADAPTOR DURING PREPARATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270898 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8171162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other