BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 12724075 · Received October 29, 2021

    Report

    Report Number
    3014704491-2021-00232
    Event Type
    Injury
    Date Received
    October 29, 2021
    Date of Event
    September 1, 2021
    Report Date
    October 31, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231182. 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. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM WAS USED AND THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, THE CLOSED VENOUS INDWELLING NEEDLE WAS APPLIED AND FIXED WITH INDWELLING NEEDLE. ABOUT 10 MINUTES LATER, DIFFERENT SIZES OF PIMPLE HERPES APPEARED AT THE PUNCTURE SITE OF THE INDWELLING NEEDLE. 3% BORIC ACID SOLUTION WAS WET APPLIED AND TRAMISIN CREAM WAS APPLIED EXTERNALLY ACCORDING TO THE DOCTOR'S ADVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM WAS USED AND THE PATIENT EXPERIENCED AN ALLERGIC REACTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2021, THE CLOSED VENOUS INDWELLING NEEDLE WAS APPLIED AND FIXED WITH INDWELLING NEEDLE. ABOUT 10 MINUTES LATER, DIFFERENT SIZES OF (B)(6) APPEARED AT THE PUNCTURE SITE OF THE INDWELLING NEEDLE. 3% BORIC ACID SOLUTION WAS WET APPLIED AND TRAMISIN CREAM WAS APPLIED EXTERNALLY ACCORDING TO THE DOCTOR'S ADVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621396 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0231182

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention