BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURECAN SAFETY II

    MDR report key: 13190078 · Received January 7, 2022

    Report

    Report Number
    9612452-2022-00002
    Event Type
    Malfunction
    Date Received
    January 7, 2022
    Date of Event
    September 14, 2018
    Report Date
    April 27, 2023
    Manufacturer
    B. BRAUN MEDICAL FRANC
    Product Code
    PTI
    UDI-DI
    04038653918164
    PMA / PMN Number
    K010485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH HISTORY REVIEW: A REVIEW OF THE MANUFACTURING RECORDS SHOWS THIS BATCH OF FILTERS COMPLIED WITH SPECIFICATIONS. NO OTHER SIMILAR COMPLAINTS WERE REPORTED TO THE MANUFACTURER FOR THIS LOT OF VENA CAVA FILTERS, SOLD SINCE JUNE 2018. INVESTIGATION: THE DEVICE IS NOT AVAILABLE FOR EVALUATION. NO X-RAY PICTURES WERE SENT FOR ANALYSIS. CONCLUSION: NO THOROUGH INVESTIGATION IS POSSIBLE AND THE EXACT ROOT CAUSE OF WHAT PREVENT THE FULL EXPANSION OF THE FILTER CANNOT BE FOUND. THIS TYPE OF INCIDENT IS A KNOW COMPLICATION OF THE VENA CAVA FILTER IMPLANTATIONS. THE COMPLAINT RATE FOR THIS TYPE OF INCIDENT ON VENATECH LP IS LOW. NO CORRECTIVE ACTION IS ENVISAGED. B BRAUN MEDICAL SAS HAS PROVIDED ALL THE INFORMATION CURRENTLY AVAILABLE. IN SPITE OF ALL REASONABLE EFFORTS BEING MADE TO OBTAIN FURTHER INFORMATION, AT THIS TIME WE HAVE NOT MET WITH SUCCESS.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). INVESTIGATION RESULTS: WE DID NOT RECEIVE THE COMPLAINT SAMPLE FOR INVESTIGATION. CONCLUSION: WITHOUT THE COMPLAINT SAMPLE AND THE BATCH NUMBER FOR INVESTIGATION, NO THOROUGH INVESTIGATION IS POSSIBLE AND WE CANNOT CONCLUDE ON THE REAL CAUSE OF THE INCIDENT ENCOUNTERED BY THE CUSTOMER. IF NEW ELEMENTS BECOME AVAILABLE IN THE FUTURE, WE WILL REOPEN THIS COMPLAINT. THIS IS A RARE INCIDENT (B)(4), NO CORRECTIVE ACTION IS ENVISAGED FOR THE MOMENT.

    Description of Event or Problem · 0

    FILTER LEGS DID NOT EXPAND FULLY DESPITE MANIPULATION WITH CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2499713 SURECAN SAFETY II NON-CORING (HUBER) NEEDLE PTI B. BRAUN MEDICAL FRANC 5010024 36933135 04038653918164
    2803634 SURECAN SAFETY II NON-CORING (HUBER) NEEDLE PTI B. BRAUN MEDICAL FRANC 5010024 36933135 04038653918164

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male