BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12373996 · Received August 26, 2021

    Report

    Report Number
    3006948883-2021-00896
    Event Type
    Malfunction
    Date Received
    August 26, 2021
    Date of Event
    July 13, 2021
    Report Date
    August 16, 2021
    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 · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1032192. 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, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/EC SLM HAD A NEEDLE THROUGH THE CATHETER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN A TROCAR WAS USED TO PERFORM VENIPUNCTURE ON THE CHILD, THE INDWELLING NEEDLE WAS CHECKED AND FOUND THAT THE NEEDLE CORE PUNCTURED THE OUTER CATHETER TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271216 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ 1032192

    Patients

    Seq Age Sex Outcome Treatment
    1