BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8048470 · Received November 7, 2018

    Report

    Report Number
    3006948883-2018-00255
    Event Type
    Injury
    Date Received
    November 7, 2018
    Date of Event
    October 22, 2018
    Report Date
    November 19, 2018
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8043027. OUR RECORDS SHOW THE REPORTED LOT WAS MANUFACTURED IN MARCH OF 2018, AND DETERMINED THAT THIS IS THE ONLY INSTANCE OF A BROKEN CATHETER 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 OF PACKAGED GOODS. ADDITIONALLY, OUR ENGINEERS REVIEWED THE SAMPLES SUBMITTED FOR EVALUATION. THE CHARACTERISTICS IDENTIFIED IN THE CATHETER TUBING OF BOTH SAMPLES WAS INDICATIVE OF AN EXTERNAL FORCE BEING APPLIED TO THE DEVICE THAT WAS CAPABLE OF PHYSICALLY RENDING THE TUBING. TO DETERMINE IF THE RAW MATERIAL USED IN THE MANUFACTURE WAS THE CAUSE, TENSILE TESTING OF OUR RETAINED SAMPLES WAS CONDUCTED; THE RESULTS OF THE TESTS FOUND THE RETAINED DEVICES TO BE WITHIN OPERATIONAL PARAMETERS, SUGGESTING THE ROOT CAUSE FOR THIS EVENT IS THE APPLICATION OF LARGE EXTERNAL FORCE DURING USE THAT EXCEEDED THE EXPECTED LIMITS OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BROKE "AFTER PATIENT PULLED THE CATHETER OUT AFTER 2 DAY" AND COULDN'T BE FOUND. IN ADDITION, THE "CATHETER COULDN'T BE FOUND OUTSIDE/CT/ULTRASONIC B". IT WAS DETERMINED VIA THE CT EXAMINATION THAT THE CATHETER COULD NOT BE FOUND IN THE PATIENT'S BODY. IT WAS ALSO REPORTED THAT THE DEPARTMENT OF SURGERY TESTED TWO CATHETERS TO CONFIRM WHETHER THEY COULD BE TORN, IN WHICH "ONE CATHETER WAS TORN, THE OTHER WAS TORN 1/3".

    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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM BROKE "AFTER PATIENT PULLED THE CATHETER OUT AFTER 2 DAY" AND COULDN'T BE FOUND. IN ADDITION, THE "CATHETER COULDN'T BE FOUND OUTSIDE/CT/ULTRASONIC B". IT WAS DETERMINED VIA THE CT EXAMINATION THAT THE CATHETER COULD NOT BE FOUND IN THE PATIENT'S BODY. IT WAS ALSO REPORTED THAT THE DEPARTMENT OF SURGERY TESTED TWO CATHETERS TO CONFIRM WHETHER THEY COULD BE TORN, IN WHICH "ONE CATHETER WAS TORN, THE OTHER WAS TORN 1/3".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888524 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8043027

    Patients

    Seq Age Sex Outcome Treatment
    0 85 YR Required Intervention