BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10022119 · Received May 4, 2020

    Report

    Report Number
    3006948883-2020-00163
    Event Type
    Malfunction
    Date Received
    May 4, 2020
    Date of Event
    April 9, 2020
    Report Date
    May 5, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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 9023815. 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; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT. THE UNITS WERE PERFORMED WITHIN PRODUCT SPECIFICATIONS. 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 H.10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 15:00, ON (B)(6)2020, NURSE WAS PUNCTURING FOR A PATIENTS WITH TUMOR WHO COULDN'T EAT THROUGH THE MOUTH , AFTER THE SUCCESS OF THE OPERATION, IT WAS FOUND THAT THERE WAS THE LEAKAGE AT THE INDWELLING NEEDLE EXPOSED END DURING THE DRIP OF NUTRIENT SOLUTION AND ACID SUPPRESSION DRUGS, IT COULDN'T CONTINUE TO USE, WHICH WAS CAUSING THE PATIENT PUNCTURED AGAIN, IT WAS INCREASED THE PATIENT'S PAIN, AND ALSO INCREASED THE NURSE'S WORK.

    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 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 15:00, ON (B)(6) 2020, NURSE WAS PUNCTURING FOR A PATIENTS WITH TUMOR WHO COULDN'T EAT THROUGH THE MOUTH, AFTER THE SUCCESS OF THE OPERATION, IT WAS FOUND THAT THERE WAS THE LEAKAGE AT THE INDWELLING NEEDLE EXPOSED END DURING THE DRIP OF NUTRIENT SOLUTION AND ACID SUPPRESSION DRUGS, IT COULDN'T CONTINUE TO USE, WHICH WAS CAUSING THE PATIENT PUNCTURED AGAIN, IT WAS INCREASED THE PATIENT'S PAIN, AND ALSO INCREASED THE NURSE'S WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483647 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9023815

    Patients

    Seq Age Sex Outcome Treatment
    1 Other