BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 15325606 · Received August 31, 2022

    Report

    Report Number
    3014704491-2022-00383
    Event Type
    Malfunction
    Date Received
    August 31, 2022
    Date of Event
    July 24, 2022
    Report Date
    September 1, 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

    DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: THE CUSTOMER RETURNED A PHOTO, NOT THE ACTUAL SAMPLE. IN THE PHOTO, THE LEAK SITE IS CIRCLED IN RED AS THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB. HOWEVER, THE SPECIFIC DAMAGE POINT AND STATE CANNOT BE IDENTIFIED. LEAKAGE TEST THE RETAINED SAMPLE OF THE COMPLAINT BATCH, THE TEST IS QUALIFIED, NO LEAKAGE IS FOUND AT THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB. NO ABNORMALITY IS FOUND ON PROCESS AND THE RETAINED SAMPLE. IN THE RETURNED PHOTO, THE LEAK SITE IS CIRCLED IN RED AS THE CONNECTION BETWEEN THE CATHETER AND THE CATHETER HUB. HOWEVER, THE SPECIFIC DAMAGE POINT AND STATE CANNOT BE IDENTIFIED, AND THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED DUE TO NO DEFECTIVE SAMPLE RETURNED. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2053256. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO THE FEEDBACK OF THE DEPARTMENT, LEAKAGE WAS FOUND WHERE THE CATHETER TUBE WAS CONNECTED WITH THE Y-SHAPED TUBE SEAT, AND THERE WAS NO SHARP OBJECT AROUND THE OPERATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO THE FEEDBACK OF THE DEPARTMENT, LEAKAGE WAS FOUND WHERE THE CATHETER TUBE WAS CONNECTED WITH THE Y-SHAPED TUBE SEAT, AND THERE WAS NO SHARP OBJECT AROUND THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773729 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2053256

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown