BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8243914 · Received January 14, 2019

    Report

    Report Number
    3006948883-2018-00416
    Event Type
    Malfunction
    Date Received
    January 14, 2019
    Date of Event
    December 20, 2018
    Report Date
    January 21, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141374. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN JUNE OF 2018; IT DETERMINED THAT THIS IS THE ONLY INSTANCE OF FOREIGN MATTER 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. ADDITIONALLY, THROUGH THE VISUAL OBSERVATION OF THE DEVICE PROVIDED, IT WAS DETERMINED THAT THE FOREIGN MATERIAL FOUND ON YOUR DEVICE WAS MOST LIKE OIL FROM OUR MANUFACTURING MACHINERY. SINCE THE CREATION OF THIS LOT WE HAVE TAKEN STEPS TO PREVENT FOREIGN MATERIAL FROM WORKING ITS WAY INTO OUR FINISHED GOOD, INCLUDING THE INSTALLMENT OF PROTECTIVE COVERS AND REMOVAL OF ANY PRESENT GREASE PRIOR TO THE START OF PRODUCTION RUN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BEFORE USE.

    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 FOREIGN MATTER WAS FOUND IN A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37976 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141374 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other