BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 13232637 · Received January 11, 2022

    Report

    Report Number
    3014704491-2021-00436
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    November 25, 2021
    Report Date
    January 23, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1230569. 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. ADDITIONALLY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING, BUT THIS LOT WAS TREATED AND RECEIVED A CERTIFICATE OF CONFORMANCE FOR STERILITY. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD INTIMA-II CLOSED IV CATHETER SYSTEM, THE PATIENT HAD AN ALLERGIC REACTION THAT REQUIRED TREATMENT WITH MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THERE WAS RED AND SWOLLEN SKIN INFECTIONS, SKIN TEMPERATURE, PAIN APPEARED AT THE PUNCTURED SITE AT THE ARM, AND THERE WAS ALSO PURULENT SECRETION APPEARED , THE NURSE IMMEDIATELY PULL OUT THE NEEDLE, THE AFFECTED LIMB WAS RAISED AT THE AFFECTED AREA, THE SKIN WAS DISINFECTED DAILY, AND BAIDUOBANG CREAM WAS APPLIED TO THE AFFECTED AREA. "

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD INTIMA-II CLOSED IV CATHETER SYSTEM, THE PATIENT HAD AN ALLERGIC REACTION THAT REQUIRED TREATMENT WITH MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THERE WAS RED AND SWOLLEN SKIN INFECTIONS, SKIN TEMPERATURE, PAIN APPEARED AT THE PUNCTURED SITE AT THE ARM, AND THERE WAS ALSO PURULENT SECRETION APPEARED , THE NURSE IMMEDIATELY PULL OUT THE NEEDLE, THE AFFECTED LIMB WAS RAISED AT THE AFFECTED AREA, THE SKIN WAS DISINFECTED DAILY, AND BAIDUOBANGCREAM WAS APPLIED TO THE AFFECTED AREA.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736977 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1230569

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention