BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ PRN Y ADAPTER

    MDR report key: 17775748 · Received September 19, 2023

    Report

    Report Number
    3014704491-2023-00568
    Event Type
    Malfunction
    Date Received
    September 19, 2023
    Date of Event
    September 1, 2023
    Report Date
    November 19, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830695
    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

    1. THE CUSTOMER RETURNED ONE USED SAMPLE. 1) THE LABELS OF THE OUTER PACKAGE OF THE SAMPLE SHOW: THE SKU IS 383062, THE BATCH CODE IS 3080074. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTO. 2) AFTER INQUIRY: THE SKU 383062 DOES NOT MATCH THE BATCH CODE 3080074 , THE SKU 383062 CORRESPONDS TO THE ACTUAL SAMPLE, THE BATCH CODE 3080074 IS WRONG. 3) THE SEPTUM OF THE SAMPLE IS DISPLACED, AND THE CATHETER HUB INJECTION HOLE IS EXPOSED. 4) CHECK THE DISTRIBUTION OF UV ADHESIVE AT THE CATHETER HUB UNDER THE PURPLE LAMP, NO ABNORMALITY IS FOUND. PLEASE SEE ATTACHMENT (B)(4) FOR THE PHOTO. 2. CAUSE ANALYSIS: 1) THE RETURNED SAMPLE IS LEAKING DUE TO DISPLACEMENT OF THE SEPTUM AND EXPOSURE OF THE CATHETER HUB INJECTION HOLE. 2) POSSIBLE FACTORS CAUSING THE DISPLACEMENT OF THE SEPTUM: NO UV ADHESIVE BONDING BETWEEN THE SEPTUM AND THE CATHETER HUB, THE SIZE OF THE SEPTUM AND THE CATHETER HUB (THE SAMPLE IS NOT MEASURED BECAUSE THE FINISHED PRODUCT CANNOT BE MEASURED MOST ACCURATELY), THE FLOW RATE AND PRESSURE OF THE LIQUID THROUGH THE INDWELLING NEEDLE, THE CONDITION OF THE CATHETER ENTERING THE BLOOD VESSEL, THE CONDITION OF THE PATIENT'S BLOOD VESSEL, ETC. 3) DURING THE ASSEMBLY PROCESS, THE ADHESIVE IS INJECTED FROM THE CATHETER HUB INJECTION HOLE, AFTER THE ADHESIVE IS DRIED, THE VISUAL INSPECTION SYSTEM CONDUCTS 100% INSPECTION, WHICH WILL AUTOMATICALLY IDENTIFY AND REMOVE DEFECTIVE PRODUCTS. THE VISUAL INSPECTION SYSTEM IS CHALLENGED WITH STANDARD SAMPLES EVERY DAY AT 7:00, 19:00 AND WHEN CHANGING PRODUCT GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTION. 4) THIS PRODUCT (SKU 383062, Y PP CONNECTOR) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. CONCLUSION(S): THE RETURNED SAMPLE IS LEAKING DUE TO DISPLACEMENT OF THE SEPTUM AND EXPOSURE OF THE CATHETER HUB INJECTION HOLE. BECAUSE THE DISTRIBUTION OF UV ADHESIVE AT THE CATHETER HUB IS NOT ABNORMAL, THE SPECIFIC USAGE OF THE INDWELLING NEEDLE IS UNKNOWN, THE ROOT CAUSE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO PAY ATTENTION TO SUCH DEFECTS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    ACCORDING TO THE FEEDBACK FROM THE CT ROOM, LIQUID LEAKAGE OCCURRED AT THE INTERFACE DURING THE USE OF THE PRODUCT. RECEIVED UPDATE FROM SALES REPRESENTATIVE, EVENT DESCRIPTION UPDATED AS FOLLOWS: 1. HAS THE EQUIPMENT BEEN DAMAGED IN ANY WAY DURING USE? IF SO, APPROXIMATELY WHERE? THE LOCATION OF THE LEAKAGE IS APPROXIMATELY AT THE CATHETER BASE, AND IT HAS NOT BEEN DAMAGED DURING USE. 2. IS THE DEVICE USED FOR MULTIPLE PUNCTURES? NO. 3. ARE SYRINGES OR PRESSURIZED SYRINGES USED TO INJECT LIQUIDS THROUGH THE DEVICE? . YES, IT IS USED FOR CT HIGH-PRESSURE INJECTION, BUT WITHIN THE SAFE VALUE. THE COMPLAINT SAMPLE IS ALSO SENT BACK, PLEASE HELP ANALYZE IT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II¿ PRN Y ADAPTER LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO THE FEEDBACK FROM THE CT ROOM, LIQUID LEAKAGE OCCURRED AT THE INTERFACE DURING THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1985716 BD INTIMA-II¿ PRN Y ADAPTER INTRAVASCUALR CATHETER FOZ BD (SUZHOU) 3080074 00382903830695

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown