BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 11611263 · Received April 2, 2021

    Report

    Report Number
    3006948883-2021-00359
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 14, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/2/2021. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9170855. 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. BASED ON THE SAMPLE SUBMITTED BY THE FACILITY OUR TEAM OF ENGINEERS HAS DETERMINED THAT HE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS EXPOSURE TO STRONG OXIDATIVE OR HOT ENVIRONMENT DURING TRANSPORTATION OR STORAGE. A REVIEW OF THE AVAILABLE RETENTION SAMPLES WAS ALSO CONDUCTED, WHICH FOUND THE DEVICES TO BE FREE OF ANY ABNORMALITIES AGING OR DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II 24GAX0.75IN PRN SLM NPVC PRN WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRN WAS DISCOLORED, THE NUMBER OF DEFECTIVE PRODUCTS WERE NOT SURE, NEEDED TO CONFIRMED WITH HOSPITAL, AND THE CLAIM SETTLEMENT ADDRESS ALSO NEEDED TO CONFIRM WITH SUPERVISOR.

    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 WAS REPORTED THAT INTIMA-II 24GAX0.75IN PRN SLM NPVC PRN WAS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PRN WAS DISCOLORED, THE NUMBER OF DEFECTIVE PRODUCTS WERE NOT SURE, NEEDED TO CONFIRMED WITH HOSPITAL, AND THE CLAIM SETTLEMENT ADDRESS ALSO NEEDED TO CONFIRM WITH SUPERVISOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504215 INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR ADMINISTRATION SET FOZ BD (SUZHOU) 9170855

    Patients

    Seq Age Sex Outcome Treatment
    1