BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC

    MDR report key: 8658552 · Received May 31, 2019

    Report

    Report Number
    3006948883-2019-00422
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 17, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023802. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF 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. ADDITIONALLY, OUR ENGINEERS WERE ABLE TO EVALUATE THE EXPANDED TUBING IN THE DEVICE SUBMITTED. BASED ON THEIR EVALUATION AND THE DESCRIPTION OF THE EVENT, THEY WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBING EXPANDED WITH A BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: IT WAS FOUND TUBE IS BULGING AND NEARLY BURSTING, WHICH CAUSES THE ALARM OF THE INSTRUMENT AND THE TERMINATION OF ENHANCED SCANNING. REPRESENTS A SUPPLEMENTARY DRIP RATE OF 3.0, < 300 PSI.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TUBING EXPANDED WITH A BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: IT WAS FOUND TUBE IS BULGING AND NEARLY BURSTING, WHICH CAUSES THE ALARM OF THE INSTRUMENT AND THE TERMINATION OF ENHANCED SCANNING. REPRESENTS A SUPPLEMENTARY DRIP RATE OF 3.0, < 300 PSI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454489 BD INTIMA-II¿ 22GAX1.00IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9023802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other