BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 10365333 · Received August 4, 2020

    Report

    Report Number
    3006948883-2020-00329
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    June 7, 2020
    Report Date
    September 14, 2020
    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 9233899. 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. BASED ON THE PROVIDED PHOTO OUR QUALITY ENGINEERS BELIEVE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO THE MANUFACTURING MACHINERY RESPONSIBLE FOR THE TOOLING OF THE ADAPTER CAVITY. INTERFERENCE BETWEEN THE MACHINERY AND THE METAL WEDGE IN THE ADAPTER HEAD CAN LEAD TO A CRACKED CASING. AFTER REVIEWING THE MANUFACTURING LINE OUR ENGINEERS WERE ABLE TO LOCATE AND REPAIR THE APPROPRIATE MACHINERY. SEE H.10..

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AND A CRACKED/BROKEN CATHETER ADAPTER/CONNECTOR/HUB. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE NURSE INJECTED THE PATIENT WITH A CLOSED INTRAVENOUS INDWELLING NEEDLE AT 9:00 A.M. ON (B)(6) 2020, SHE FOUND THAT THERE WAS LIQUID EFFUSION AROUND THE Y TYPE JUNCTION AND INDWELLING NEEDLE HUB, AFTER CHECKED, THERE WAS A FRACTURE IN THE Y TYPE INDWELLING NEEDLE CONNECTION SEAT, AND PERFORMED PUNCTURE TRANSFUSION AFTER THE INDWELLING NEEDLE WAS REMOVED AND REPLACED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AND A CRACKED/BROKEN CATHETER ADAPTER/CONNECTOR/HUB. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE NURSE INJECTED THE PATIENT WITH A CLOSED INTRAVENOUS INDWELLING NEEDLE AT 9:00 A.M. ON (B)(6) 2020, SHE FOUND THAT THERE WAS LIQUID EFFUSION AROUND THE Y TYPE JUNCTION AND INDWELLING NEEDLE HUB, AFTER CHECKED, THERE WAS A FRACTURE IN THE Y TYPE INDWELLING NEEDLE CONNECTION SEAT, AND PERFORMED PUNCTURE TRANSFUSION AFTER THE INDWELLING NEEDLE WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829652 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other