BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN MZ SLM NPVC

    MDR report key: 12631549 · Received October 14, 2021

    Report

    Report Number
    3014704491-2021-00198
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    August 6, 2021
    Report Date
    September 23, 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 REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050858. 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 RESULTS OF THESE SHOW THAT THE TESTED UNITS 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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE INTIMA-II 24GAX0.75IN MZ SLM NPVC THE CATHETER ADAPTER/CONNECTOR/HUB - WAS NOT ABLE TO CONNECT TO THE MATING COMPONENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE POSITIVE PRESSURE CONNECTOR OF THE INDWELLING NEEDLE COULD NOT BE CONNECTED TO THE NEEDLE TUBE WHEN THE NURSE GAVE THE CHILD TRANSFUSION. THE POSITIVE PRESSURE CONNECTOR ON THE INDWELLING NEEDLE WAS IMMEDIATELY REPLACED WITHOUT ADVERSE EFFECTS ON THE PATIENT AND REPORTED TO THE EQUIPMENT DEPARTMENT FOR TREATMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534696 INTIMA-II 24GAX0.75IN MZ SLM NPVC INTRAVASCULAR CATHETER FOZ 8198210

    Patients

    Seq Age Sex Outcome Treatment
    1