BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8540778 · Received April 23, 2019

    Report

    Report Number
    3006948883-2019-00282
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    April 6, 2019
    Report Date
    May 31, 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 NUMBER8288246. 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. SAMPLES WERE RETURNED AND COMPARED WITH THE RETAINED SAMPLES. OUR ENGINEERS HAVE REVIEWED THIS EVENT AND DETERMINED THAT THE MOST LIKELY ROOT CAUSE IS THE COMBINED USE OF OMEGA AND OREOTIDE. THIS MIXTURE IS KNOWN TO TURN BROWN AFTER APPROXIMATELY 2 HOURS AND LIKELY WOULD HAVE STAINED THE EXTENSION TUBING.

    Description of Event or Problem · 0

    A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233350. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 THERE WERE 6 OCCURRENCES OF FOREIGN MATTER WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS (B)(6) YEARS OLD WITH GASTROINTESTINAL BLEEDING. USING OMEGA+OCTREOTIDE WAS INFUSED INFUSING FOR 24 HOURS. DURING THE INFUSION, THE NURSES FOUND THAT THE INTIMA II WAS GRADUALLY DISCOLORED, AND INTIMA II WAS REMOVED IMMEDIATELY AFTER THE INFUSION. THERE WERE NO ADVERSE REACTIONS. SIMILAR PROBLEMS OCCURRED AGAIN WHEN THE SECOND INFUSION WAS REPLACED. THE HEAD NURSES FEEDBACK THAT THE SAME TREATMENT PLAN DID NOT HAPPEN IN THE PAST, SO IT IS NECESSARY TO EXCLUDE THE QUALITY PROBLEMS OF THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335149 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCLUAR CATHETER FOZ BD (SUZHOU) 8288246

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Other