BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LACERATION KIT

    MDR report key: 24617344 · Received March 17, 2026

    Report

    Report Number
    1030451-2026-00004
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 17, 2026
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    OVN
    UDI-DI
    40612479182361
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE DEVICE HISTORY RECORD THERE WERE NO NONCONFORMANCES DURING PRODUCTION OF THE COMPLAINT LOT. INSPECTION AND RELEASE PROCESSES WERE FOLLOWED. BASED ON THOSE PROCESSES, THE FINISHED GOOD WAS DETERMINED TO BE CONFORMING AT THE TIME OF COMMERCIAL DISTRIBUTION. A 12 MONTH REVIEW SHOWED NO SIGNIFICANT TRENDS FOR THIS ISSUE OR INVOLVING THIS KIT OR THIS INSTRUMENT. SUPPLIER, GLOBAL INSTRUMENTS INC. ROOT CAUSE ANALYSIS IDENTIFIED THE FOLLOWING ROOT CAUSE(S): TOOL WEAR AND ALIGNMENT VARIATIONS DURING MANUFACTURING WHEREBY FINAL INSPECTION FAILED TO DETECT ISSUES. GLOBAL INSTRUMENTS INC. IMPLEMENTED THE FOLLOWING CORRECTIVE ACTIONS: ¿ REWORK OR REJECTION OF NON-CONFORMING INSTRUMENTS ¿ TOOLING INSPECTION AND RECALIBRATION ¿ ENHANCED FUNCTIONAL INSPECTION OF JAW ALIGNMENT, LOCKING, AND GRIPPING FORCE ¿ IMPROVED CLEANING AND SURFACE VERIFICATION PRIOR TO FINAL INSPECTION ¿ REINFORCEMENT OF INSPECTION CRITERIA WITH QA AND PRODUCTION STAFF THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    INCIDENT ONE: THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE CONVENIENCE KIT CONTAINING THE COMPLAINT COMPONENT, R0598, LOTS 2513R0598 AND 2504R0598, PURCHASED FROM SPECIFICATION DEVELOPER, GLOBAL INSTRUMENTS INC. (FDA REGISTRATION 1057200). THIS PRODUCT INCIDENT IS DOCUMENTED IN THE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THE HEMOSTAT BREAKING WHILE IN USE. THERE WERE NO PATIENT INJURY AND NO MEDICAL INTERVENTION REQUIRED. THE CUSTOMER CONFIRMED THE INSTRUMENT WAS CLAMPED ON THE CATHETER WHEN IT BROKE WHILE REMOVING THE CATHETER DURING ROUTINE PROCEDURE (NOT EMERGENCY PROCEDURE). THERE WAS DELAY OF APPROXIMATELY A FEW MINUTES FOR EACH PROCEDURE INVOLVED DURING CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685309 LACERATION KIT LACERATION KIT OVN MEDICAL ACTION INDUSTRIES 25-2748 329680 40612479182361

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown