BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER

    MDR report key: 12256631 · Received July 30, 2021

    Report

    Report Number
    3014704491-2021-00055
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Date of Event
    July 4, 2021
    Report Date
    July 20, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0140316. 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. A SAMPLE WAS SUBMITTED THAT DISPLAYED A BREAK IN THE CATHETER TUBING. REPORTED NON-CONFORMANCE HAS BEEN CONFIRMED. BASED ON VISUAL ANALYSIS OF THE BROKEN EDGE, OUR ENGINEERS WERE ABLE TO IDENTIFY A SMOOTH EDGE AND AN INCLINED PLANE. BOTH OF THESE CHARACTERISTICS ARE CONSISTENT WITH DAMAGE SUSTAINED FROM CONTACT WITH A SHARP EDGE OR CUTTING INSTRUMENT. ADDITIONALLY A REVIEW OF THE MANUFACTURING PROCESS WAS CONDUCTED; OUR ENGINEERS WERE UNABLE TO LOCATE ANY SHARP SURFACES THAT COULD HAVE RESULTED IN THE OBSERVED DAMAGE AND CUTTING INSTRUMENTS ARE NOT PERMITTED ON THE MANUFACTURING FLOOR. BASED ON THE AVAILABLE INFORMATION OUR ENGINEERS WERE NOT ABLE TO ASSOCIATE THIS NON-CONFORMANCE WITH THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD INTIMA¿-II CLOSED IV CATHETER THE CATHETER BROKE. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN USING THE INTIMA-II, THE CATHETER WAS BROKE. ADDITIONALLY, THE BD SALES CONSULTANT PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: THE CATHETER WAS PLACED IN THE MORNING OF JULY 3, AND THE INDWELLING NEEDLE PUNCTURE SITE IN THE HEAD OF THE CHILD WAS FOUND TO BE INCOMPLETE AND THE NEEDLE WAS BROKEN IN THE MORNING OF JULY 4. LATER, THE CATHETER WAS FOUND TO BE BROKEN IN THE APPLICATION FOUND THAT THE BROKEN PIPE WAS APPLIED EXTERNALLY. REMOVE THE BROKEN PIPE COMPLETELY. THE DRUGS THE PATIENT INPUTS ARE ROUTINE DRUGS. THE PATIENT HAD NORMAL RESTLESSNESS AND NO MENTAL ABNORMALITIES. THE PATIENT IS IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150079 BD INTIMA-II CLOSED IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0140316

    Patients

    Seq Age Sex Outcome Treatment
    1