BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9581780 · Received January 13, 2020

    Report

    Report Number
    3006948883-2019-01194
    Event Type
    Malfunction
    Date Received
    January 13, 2020
    Date of Event
    December 10, 2019
    Report Date
    February 24, 2020
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141669. 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, ALTHOUGH A SAMPLE WAS NOT PROVIDED FOR EVALUATION. PREVIOUS INSTIGATION'S HAVE SHOWN THAT A LARGE BEND SUGGESTS A LARGE FORCE WAS APPLIED TO THE PACKAGING UNIT AFTER THE DEVICE HAD LEFT THE MANUFACTURING FACILITY, MOST LIKELY DURING SHIPPING. THE SHIPPING COMPANY HAS BEEN NOTIFIED OF THE SITUATION AND BD STANDARDS AND EXPECTATIONS HAVE BEEN RECOMMUNICATED. A CAPA # 1278509 HAS BEEN OPENED. THE FINDINGS FROM THIS CAPA FOUND THAT THE EMPLOYEES DURING THE SHIPPING AND PACKING PROCESS STEPPED ON THE BOX TO GET INTO THE TRUCK. A CORRECTIVE ACTION HAS BEEN PUT INTO PLACE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROKEN NEEDLE WAS FOUND BEFORE USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PUNCTURING, THE PACKAGE WAS OPENED AND THE NEEDLE WAS BROKEN AND BENT. THEN THE INDWELLING NEEDLE WAS REPLACED FOR PUNCTURING."

    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 BROKEN NEEDLE WAS FOUND BEFORE USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "DURING THE PUNCTURING, THE PACKAGE WAS OPENED AND THE NEEDLE WAS BROKEN AND BENT. THEN THE INDWELLING NEEDLE WAS REPLACED FOR PUNCTURING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47519 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141669

    Patients

    Seq Age Sex Outcome Treatment
    1 Other