BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERI

    MDR report key: 22408187 · Received July 5, 2025

    Report

    Report Number
    3017101761-2025-00001
    Event Type
    Injury
    Date Received
    July 5, 2025
    Date of Event
    June 4, 2025
    Report Date
    July 3, 2025
    Manufacturer
    IC SURGICAL INC
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REVIEWED THE RECORDS FOR THE APPLICABLE LOT OF THE MANIFOLD ASSEMBLY. THE MANUFACTURER NOTED THERE WERE NO NONCONFORMANCES ON THIS LOT. A TOTAL OF 401 PCS WERE MADE, 3 WERE REJECTED FOR EMBEDDED PARTICULATE, AND THE REMAINING 398 WERE SHIPPED. NO OTHER IRREGULARITIES WERE NOTED. THE 2 PIECES OF THE MANIFOLD REMOVED FROM THE PATIENT WERE RETURNED FOR A FULL INVESTIGATION. WHILE NO ROOT CAUSE COULD BE DETERMINED FOR THIS SPECIFIC FAILURE THEY WERE ABLE TO DETERMINE THAT THE BRANCHES WERE ALL INTACT AND REMAINED SECURED INTO THE JUNCTION, THE DRAIN TUBE WAS ALSO INTACT AND REMAINED SECURED INTO THE JUNCTION'S OTHER HALF. THE JUNCTION WAS SEPARATED INTO TWO DISTINCT HALVES WITH IRREGULAR EDGES. OTHER THAN A SMALL TEAR AT THE BRANCHES END OF THE JUNCTION THERE WAS NO OTHER DAMAGE FOUND TO THE MATERIAL OF THE JUNCTION. NO DEFINITIVE ROOT CAUSE CAN BE IDENTIFIED FOR THIS SPECIFIC FAILURE. WHILE THE MIDDLE OF THE JUNCTION AND THE JUNCTION MATERIAL IS NOT SPECIFICALLY TESTED IN DESIGN VERIFICATION, BASED ON THE MATERIAL PROPERTIES THE EXPECTED MATERIAL STRENGTH IS GREATER THAN THE STRENGTH OF THE TWO ENDS AND MORE THAN NECESSARY FOR THE INTENDED USE. THE TENSILE STRENGTH OF THE BONDS AT THE ENDS OF THE JUNCTION EXCEED THE REQUIREMENT OF 30N WHICH IS BASED ON THE STANDARDS FOR DRAIN TUBES. IT IS POSSIBLE IF THE MATERIAL IS DAMAGED, NICKED, SCRATCHED, ETC., THAT A POTENTIAL TEAR COULD PROPAGATE FROM THAT DAMAGE MORE EASILY. BASED ON THE LOCATION OF THE TEAR IN THIS SITUATION, AND THAT IT IS THE LOCATION THAT IS SUTURED INTO PLACE, THIS REMAINS A POTENTIAL CAUSE, BUT CANNOT BE DEFINITIVELY DETERMINED. AS THIS IS THE FIRST REPORTED OCCURRENCE OF THIS ADVERSE EVENT, THE MANUFACTURER WILL CLOSELY MONITOR AND TREND FOR ANY FUTURE OCCURRENCES.

    Description of Event or Problem · 0

    THE PATIENT HAD A DRAIN PLACED APPROXIMATELY 2.5 WEEKS PRIOR DURING BACK SURGERY. DURING A FOLLOW-UP VISIT, THE PATIENT CAME INTO THE OFFICE FOR A DRAIN REMOVAL PROCEDURE. DURING THE PROCEDURE, THE MANIFOLD JUNCTION PORTION OF THE DRAIN WHERE THE EXTERNALLY FACING TUBE CONNECTS TO THE INTERNAL DRAIN BRANCHES BROKE. THE INTERNAL PORTION OF THE DEVICE (DRAIN BRANCHES) COULD NOT BE ACCESSED FOR REMOVAL OR EASILY GRASPED THROUGH THE EXIT SITE TO REMOVE THE DEVICE AS INTENDED. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TRANSPORTED TO THE OR SO THAT THEY COULD HAVE THE DEVICE SURGICALLY REMOVED. THE PHYSICIAN WAS ABLE TO IDENTIFY THE END OF THE DEVICE UNDER FLORO, MADE AN INCISION ON THE PATIENT, WAS ABLE TO SECURE THE REMAINING PORTION OF THE DEVICE, AND REMOVE IT WITHOUT RESISTANCE OR FURTHER COMPLICATION. THE PHYSICIAN PLACED A STANDARD BLAKE DRAIN AND THE PATIENT WAS DISCHARGED THE NEXT DAY. BOTH SECTIONS OF THE REMOVED PORTION OF THE DEVICE WERE DETERMINED TO BE COMPLETELY INTACT AND SENT TO MANUFACTURER FOR ADDITIONAL INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2818559 INTERI SURGICAL DRAIN GCY IC SURGICAL INC K401200 875317

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Hospitalization