BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9526389 · Received December 27, 2019

    Report

    Report Number
    3006948883-2019-01131
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    July 8, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233335. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS USED AND THE PATIENT HAD A SKIN REACTION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON JULY 1, THE PATIENT WAS ADMITTED TO HOSPITAL ACCORDING TO THE EMERGENCY PLAN OF "LEFT CALF SOFT TISSUE FILE ABRASION". AFTER ADMISSION, THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSION WITH INDWELLING NEEDLE IN THE LEFT FOREARM (APRICOTINE). ON JULY 3, THE INDWELLING NEEDLE EYE WAS SLIGHTLY RED, AND THE INDWELLING NEEDLE WAS REMOVED. ON THE MORNING OF JULY 4, THE PATIENT'S LEFT FOREARM INDWELLING NEEDLE EYE WAS RED, WITH LOCAL INDWELLING, DAMAGE, AND A SMALL AMOUNT OF INFILTRATION, WITH A RANGE OF ABOUT 1.5CM*1.5CM. ON JULY 5, THE INDWELLING NEEDLE INFUSION WAS GIVEN TO THE RIGHT WRIST, AND THE INDWELLING NEEDLE WAS REMOVED AT 17:00 P.M. ON THE MORNING OF JULY 6, 1CM*1CM SKIN REDNESS AND A SMALL AMOUNT OF EXUDATION WERE OBSERVED AT THE PUNCTURE SITE OF THE INDWELLING NEEDLE IN THE RIGHT WRIST. AFTER CONSULTATION, THE ULCER WAS APPLIED FOR EXTERNAL USE.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS USED AND THE PATIENT HAD A SKIN REACTION. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON JULY 1, THE PATIENT WAS ADMITTED TO HOSPITAL ACCORDING TO THE EMERGENCY PLAN OF "LEFT CALF SOFT TISSUE FILE ABRASION". AFTER ADMISSION, THE PATIENT WAS TREATED WITH INTRAVENOUS INFUSION WITH INDWELLING NEEDLE IN THE LEFT FOREARM (APRICOTINE). ON JULY 3, THE INDWELLING NEEDLE EYE WAS SLIGHTLY RED, AND THE INDWELLING NEEDLE WAS REMOVED. ON THE MORNING OF JULY 4, THE PATIENT'S LEFT FOREARM INDWELLING NEEDLE EYE WAS RED, WITH LOCAL INDWELLING, DAMAGE, AND A SMALL AMOUNT OF INFILTRATION, WITH A RANGE OF ABOUT 1.5CM*1.5CM. ON JULY 5, THE INDWELLING NEEDLE INFUSION WAS GIVEN TO THE RIGHT WRIST, AND THE INDWELLING NEEDLE WAS REMOVED AT 17:00 P.M. ON THE MORNING OF JULY 6, 1CM*1CM SKIN REDNESS AND A SMALL AMOUNT OF EXUDATION WERE OBSERVED AT THE PUNCTURE SITE OF THE INDWELLING NEEDLE IN THE RIGHT WRIST. AFTER CONSULTATION, THE ULCER WAS APPLIED FOR EXTERNAL USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318867 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FOZ BD (SUZHOU) 8233335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other