BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9536055 · Received December 31, 2019

    Report

    Report Number
    3006948883-2019-01149
    Event Type
    Malfunction
    Date Received
    December 31, 2019
    Date of Event
    December 4, 2019
    Report Date
    January 27, 2020
    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

    H.6. INVESTIGATION:A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 7019473. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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 THE 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, DUE TO POSTCIRCULATIVE ISCHEMIA, THE PATIENT WAS GIVEN 250ML NORMAL SALINE AND 400MG PUERARIN INJECTION. DURING INTRAVENOUS INFUSION, THE INDWELLING NEEDLE LEAKAGE WAS FOUND DURING THE EXAMINATION OF INDWELLING NEEDLE, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II EXPERIENCED LEAKAGE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2019, DUE TO POSTCIRCULATIVE ISCHEMIA, THE PATIENT WAS GIVEN 250ML NORMAL SALINE AND 400MG PUERARIN INJECTION. DURING INTRAVENOUS INFUSION, THE INDWELLING NEEDLE LEAKAGE WAS FOUND DURING THE EXAMINATION OF INDWELLING NEEDLE, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331595 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7019473

    Patients

    Seq Age Sex Outcome Treatment
    1 Other