BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10924535 · Received November 30, 2020

    Report

    Report Number
    3006948883-2020-00862
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    October 10, 2020
    Report Date
    January 4, 2021
    Manufacturer
    BD (SUZHOU)
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141669. 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. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO OUR DEPARTMENT DUE TO "RESPIRATORY FAILURE" ON (B)(6) 2020. WHEN THE INDWELLING NEEDLE WAS CLOSED AT THE END OF INFUSION, IT WAS FOUND THAT THE VENOUS INDWELLING NEEDLE CONNECTION WAS BROKEN. A PRELIMINARY INSPECTION OF THE INDWELLING NEEDLE SHOWED THAT THE ROOT OF THE CONNECTING PIPE WAS BROKEN. INTRAVENOUS INDWELLING NEEDLE SHOULD BE REMOVED IMMEDIATELY. LOOK FOR OTHER INDWELS WITH THE SAME BATCH NUMBER, TAKE PHOTOS OF THE PROBLEM PRODUCTS AND REPORT TO THE PROCUREMENT OFFICE. THIS SITUATION DID NOT HAPPEN AGAIN. NO ADVERSE CONSEQUENCES.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO OUR DEPARTMENT DUE TO "RESPIRATORY FAILURE" ON (B)(6) 2020. WHEN THE INDWELLING NEEDLE WAS CLOSED AT THE END OF INFUSION, IT WAS FOUND THAT THE VENOUS INDWELLING NEEDLE CONNECTION WAS BROKEN. A PRELIMINARY INSPECTION OF THE INDWELLING NEEDLE SHOWED THAT THE ROOT OF THE CONNECTING PIPE WAS BROKEN. INTRAVENOUS INDWELLING NEEDLE SHOULD BE REMOVED IMMEDIATELY. LOOK FOR OTHER INDWELS WITH THE SAME BATCH NUMBER, TAKE PHOTOS OF THE PROBLEM PRODUCTS AND REPORT TO THE PROCUREMENT OFFICE. THIS SITUATION DID NOT HAPPEN AGAIN. NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384487 INTIMA-II Y 24GAX0.75IN PRN/PRN SLM NPVC CATHETER FOZ BD (SUZHOU) 9141669

    Patients

    Seq Age Sex Outcome Treatment
    1