BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 13232730 · Received January 11, 2022

    Report

    Report Number
    3014704491-2021-00438
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    November 27, 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. 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: " IT WAS FOUND THAT THERE WAS INFLAMED SKIN INFECTIONS APPEARED AT THE NEEDLE EYE ON THE THIRD OF INDWELLING, THE NURSE IMMEDIATELY PULL OUT INDWELLING NEEDLE, GIVE UP AFFECTED LIMB, AFTER ROUTINE DISINFECTION COLLOID MATERIAL APPLIED TO THE WATER, AND THREE YELLOW CREAM USED INTERCHANGEABLY. THE PAIN WAS NOT ALLEVIATED IN TIME, AND PURPUREUS SECRETIONS APPEARED AT THE EYE OF THE NEEDLE ON THE FOURTH DAY. BAIDUOBANG CREAM WAS APPLIED TO THE AFFECTED AREA, AND DICLOFENAC SODIUM SUSTAINED RELEASE TABLET WAS TAKEN ORALLY. "

    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: " IT WAS FOUND THAT THERE WAS INFLAMED SKIN INFECTIONS APPEARED AT THE NEEDLE EYE ON THE THIRD OF INDWELLING, THE NURSE IMMEDIATELY PULL OUT INDWELLING NEEDLE, GIVE UP AFFECTED LIMB, AFTER ROUTINE DISINFECTION COLLOID MATERIAL APPLIED TO THE WATER, AND THREE YELLOW CREAM USED INTERCHANGEABLY. THE PAIN WAS NOT ALLEVIATED IN TIME, AND PURPUREUS SECRETIONS APPEARED AT THE EYE OF THE NEEDLE ON THE FOURTH DAY. BAIDUOBANG CREAM WAS APPLIED TO THE AFFECTED AREA, AND DICLOFENAC SODIUM SUSTAINED RELEASE TABLET WAS TAKEN ORALLY. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037325 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