BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 9308994 · Received November 12, 2019

    Report

    Report Number
    3006948883-2019-00939
    Event Type
    Malfunction
    Date Received
    November 12, 2019
    Date of Event
    October 6, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050920. 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 BY YOUR FACILITY FOR EVALUATION. PREVIOUS INVESTIGATIONS 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.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT ONE INTIMA-II Y 24GAX0.75IN PRN/EC SLM HAS BEEN FOUND WITH A KINKING CATHETER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DUE TO SEVERE PNEUMONIA, THE PATIENT WAS TREATED WITH CLOSED INDWELLING NEEDLE INTRAVENOUS INFUSION ON (B)(6) 2019. DURING THE OPERATION, THE NEEDLE WAS FOUND TO BE BENT, AND THE NEEDLE WAS IMMEDIATELY STOPPED USING. A NEW INDWELLING NEEDLE WAS REPLACED, AND THERE WAS NO INFLUENCE TO PATIENT.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT ONE INTIMA-II Y 24GAX0.75IN PRN/EC SLM HAS BEEN FOUND WITH A KINKING CATHETER BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: DUE TO SEVERE PNEUMONIA, THE PATIENT WAS TREATED WITH CLOSED INDWELLING NEEDLE INTRAVENOUS INFUSION ON (B)(6) 2019. DURING THE OPERATION, THE NEEDLE WAS FOUND TO BE BENT, AND THE NEEDLE WAS IMMEDIATELY STOPPED USING. A NEW INDWELLING NEEDLE WAS REPLACED, AND THERE WAS NO INFLUENCE TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103200 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050920 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other