BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 10418410 · Received August 17, 2020

    Report

    Report Number
    3006948883-2020-00351
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    March 9, 2020
    Report Date
    September 4, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171135. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. HOWEVER, BASED ON PREVIOUS INVESTIGATIONS OUR QUALITY ENGINEERS WERE ABLE TO DETERMINE THAT THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS THE FORCING OF FLUID THROUGH THE DEVICE DURING INJECTION. THE BD INTIMA-II IS AN INFUSION ONLY DEVICE AND IS NOT RATED FOR HIGH PRESSURE INJECTIONS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 20GAX1.16IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENTS AROUND 11:30 A.M. FROM WARD TO DO BREAST ENHANCEMENT CT IMAGE DIVISION, IODINE ALLERGY TEST, 1 ML IODINE ALCOHOL 4 ML SALINE SEA, NO ALLERGIC REACTION, SKIN TEST 20 MINUTES LATER TO THE CT ROOM, FITTING OF HIGH PRESSURE SYRINGE READY FOR INSPECTION, THE PRESSURE TO 3.5, AFTER 8 ML MEDICINE, FAMILY MEMBERS TOLD DRUG LEAKAGE, TECHNICIAN IMMEDIATELY STOP EXAMINING A PATIENT AND DRUG LEAKAGE INTO THE ROOM, FOUND IN THE IV PLASTIC CLIP AT THE TOP OF THE HOSE HAVE SPLIT, LEAD TO LEAKAGE, REPLACEMENT AFTER 22 G NEEDLE INSPECTION SUCCESSFULLY".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 20 GA X 1.16 IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PATIENTS AROUND 11:30 A.M. FROM WARD TO DO BREAST ENHANCEMENT CT IMAGE DIVISION, IODINE ALLERGY TEST, 1 ML IODINE ALCOHOL 4 ML SALINE SEA, NO ALLERGIC REACTION, SKIN TEST 20 MINUTES LATER TO THE CT ROOM, FITTING OF HIGH PRESSURE SYRINGE READY FOR INSPECTION, THE PRESSURE TO 3.5, AFTER 8 ML MEDICINE, FAMILY MEMBERS TOLD DRUG LEAKAGE, TECHNICIAN IMMEDIATELY STOP EXAMINING A PATIENT AND DRUG LEAKAGE INTO THE ROOM, FOUND IN THE IV PLASTIC CLIP AT THE TOP OF THE HOSE HAVE SPLIT, LEAD TO LEAKAGE, REPLACEMENT AFTER 22 G NEEDLE INSPECTION SUCCESSFULLY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876628 INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8171135

    Patients

    Seq Age Sex Outcome Treatment
    1 Other