BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II

    MDR report key: 9251921 · Received October 29, 2019

    Report

    Report Number
    3006948883-2019-00884
    Event Type
    Malfunction
    Date Received
    October 29, 2019
    Date of Event
    September 9, 2019
    Report Date
    November 5, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    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 7200335. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. FIVE RETAINED SAMPLES WERE TESTED FOR LEAKAGE AND NO LEAKAGE WAS OBSERVED. 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 HAS BEEN REPORTED THAT ONE 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 DUE TO "PERINEAL ABSCESS". AFTER SURGERY, SHE WAS GIVEN INTIMA-II WITH INDWELLING CATHETER FOR TREATMENT. AFTER INDWELLING, THE INDWELLING LINK TUBE WAS FOUND TO LEAK LIQUID, PULLED OUT (THE CATHETER) FOR THE PATIENT IMMEDIATELY, AND RE-PUNCTURED.

    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 HAS BEEN REPORTED THAT ONE 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II HAS BEEN FOUND EXPERIENCING LEAKAGE DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2019 DUE TO "PERINEAL ABSCESS". AFTER SURGERY, SHE WAS GIVEN INTIMA-II WITH INDWELLING CATHETER FOR TREATMENT. AFTER INDWELLING, THE INDWELLING LINK TUBE WAS FOUND TO LEAK LIQUID, PULLED OUT (THE CATHETER) FOR THE PATIENT IMMEDIATELY, AND RE-PUNCTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048167 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7200335

    Patients

    Seq Age Sex Outcome Treatment
    1 Other