BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9104681 · Received September 23, 2019

    Report

    Report Number
    3006948883-2019-00789
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    March 20, 2019
    Report Date
    October 21, 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: NEITHER SAMPLE OR PHOTO WAS RETURNED. WITH THE LACK OF A SAMPLE, BD WAS UNABLE TO OBSERVE THE FAILURE MODE. MASTER PRODUCTION RECORDS WERE REVIEWED FOR THE LOT NUMBER AND NO NON-CONFORMANCES WERE NOTED DURING THE MANUFACTURING OF THIS LOT. OUR RECORDS INDICATE THAT THE REVIEWED BATCH RECORD PASSED ALL THE IN-PROCESS INSPECTION. A POSSIBLE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME.

    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: DURING THE USE OF THE PATIENT ON (B)(6) 2019, THE NEEDLE HOSE WAS EXUDED AND DID NOT CAUSE ANY HARM TO THE PATIENT.

    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: DURING THE USE OF THE PATIENT ON (B)(6) 2019, THE NEEDLE HOSE WAS EXUDED AND DID NOT CAUSE ANY HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901710 24G X 0.75IN (0.7 X 19 MM) W/ Y INTIMA II INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7178204

    Patients

    Seq Age Sex Outcome Treatment
    1 Other