BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15601690 · Received October 13, 2022

    Report

    Report Number
    3014704491-2022-00485
    Event Type
    Malfunction
    Date Received
    October 13, 2022
    Date of Event
    September 15, 2022
    Report Date
    October 11, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT#: 2082612, MEDICAL DEVICE EXPIRATION DATE: 25-APR-2025, DEVICE MANUFACTURE DATE: 23-MAR-2022, MEDICAL DEVICE LOT#: 2054845, MEDICAL DEVICE EXPIRATION DATE: 08-MAR-2025, DEVICE MANUFACTURE DATE: 23-FEB-2022, MEDICAL DEVICE LOT#: 2011057, MEDICAL DEVICE EXPIRATION DATE: 28-JAN-2025, DEVICE MANUFACTURE DATE: 11-JAN-2022. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER: 2082612, 2054845, 2011057. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THESE LOTS WERE ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY A SAMPLE WAS PROVIDED TO AID IN OUR INVESTIGATION. OUR ENGINEERS NOTED THAT THE RETURNED SAMPLE DISPLAYED A YELLOWING OF THE LATEX PLUG. THIS ISSUE IS NOT RELATED TO FOREIGN MATTER BUT IS INSTEAD CAUSED BY AGING OF THE LATEX DUE TO EXPOSURE TO HEAT OR OXIDATIVE ENVIRONMENTS. THE ISSUE HAS BEEN CONFIRMED. AFTER A COMPARATIVE REVIEW OF THE AVAILABLE RETENTION SAMPLE, OUR ENGINEERS WERE UNABLE TO IDENTIFY ANY ADDITIONAL INSTANCES OF LATEX AGING. THIS SUGGESTS THAT THE CAUSE FOR THIS EVENT OCCURRED POST-PRODUCTION, DURING EITHER THE TRANSPORTATION OR STORAGE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 22 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS EXPERIENCED DAMAGE PRNS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THE HEAD NURSE OF CARDIOVASCULAR MEDICINE REPORTED THAT THE PRNS WERE CHAPPED AND THE SURFACES WERE UNEVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2273135 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown