BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 11810280 · Received May 11, 2021

    Report

    Report Number
    3006948883-2021-00539
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 9, 2021
    Report Date
    May 14, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1021276. 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 THERE WAS AN INFECTION OF THE PUNCTURE SITE WHILE USING INTIMA-II Y 24GAX0.75IN PRN/EC SLM. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFECTION OF PUNCTURE SITE WAS FOUND DURING EXTUBATION OF INDWELLING NEEDLE IN CARDIOLOGY DEPARTMENT OF HOSPITAL.

    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 THERE WAS AN INFECTION OF THE PUNCTURE SITE WHILE USING INTIMA-II Y 24GAX0.75IN PRN/EC SLM. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INFECTION OF PUNCTURE SITE WAS FOUND DURING EXTUBATION OF INDWELLING NEEDLE IN CARDIOLOGY DEPARTMENT OF HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706103 INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER FOZ BD (SUZHOU) 1021276

    Patients

    Seq Age Sex Outcome Treatment
    1 Other