BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 12010915 · Received June 16, 2021

    Report

    Report Number
    3006948883-2021-00691
    Event Type
    Malfunction
    Date Received
    June 16, 2021
    Date of Event
    May 19, 2021
    Report Date
    June 17, 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 · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231275 . 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 A SAMPLE WAS RETURNED BY THE FACILITY TO AID IN OUR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE OUR ENGINEERS WERE ABLE TO LOCATE A SMALL INCISION IN THE EXTENSION TUBING LOCATED NEAR THE ADAPTER BODY. AFTER A SUBSEQUENT REVIEW OF THE MANUFACTURING FACILITY OUR ENGINEERS HAVE DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO A MISALIGNMENT IN THE ASSEMBLY MACHINERY. TWO RETAIN SAMPLES WERE TESTED FOR LEAKAGE AND BOTH PASSED. THE CONNECTION BETWEEN THE EXTENSION TUBE AND CONNECTION SEAT OF THE SAMPLE WAS ALSO CHECKED WITH NO ABNORMALITIES FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLUID LEAKED FROM THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "AFTER THE PUNCTURE IN THE DEPARTMENT OF NEUROLOGY, FLUID LEAKED AT THE JUNCTION BETWEEN THE EXTENSION TUBE AND THE CONNECTING SEAT.".

    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 FLUID LEAKED FROM THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AFTER THE PUNCTURE IN THE DEPARTMENT OF NEUROLOGY, FLUID LEAKED AT THE JUNCTION BETWEEN THE EXTENSION TUBE AND THE CONNECTING SEAT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907697 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0231275

    Patients

    Seq Age Sex Outcome Treatment
    1