BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8095315 · Received November 21, 2018

    Report

    Report Number
    3006948883-2018-00276
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 1, 2018
    Report Date
    December 19, 2018
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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

    A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171171. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN JULY OF 2018 AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF A DAMAGED CATHETER OCCURRING IN THIS BATCH OF INTIMA II. 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 BY YOUR FACILITY, 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 · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II CLOSED IV CATHETER SYSTEM BLOOD LEAKED FROM THE NEEDLE CORE.

    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 BLOOD LEAKED FROM THE NEEDLE CORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936863 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 8171171 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other