BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL SURGERY TRAY

    MDR report key: 21793157 · Received April 7, 2025

    Report

    Report Number
    1823410-2025-00001
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 17, 2025
    Report Date
    May 6, 2025
    Manufacturer
    OWENS & MINOR DISTRIBUTION, INC.
    Product Code
    LRO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. OWENS & MINOR DISTRIBUTION, INC. IS THE MANUFACTURER OF THE SURGITRACK CONVENIENCE KIT CONTAINING THE AMERICAN CONTRACT SYSTEMS (ACS) KIDNEY CUSTOM PROCEDURE TRAY WHICH WAS THE SOURCE OF THE COMPLAINT ISSUE. THE COMPLAINT PRODUCT WAS MANUFACTURED BY AMERICAN CONTRACT SYSTEMS OF KANSAS CITY, THIS MANUFACTURING SITE IS NOW CLOSED. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION. 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.

    Additional Manufacturer Narrative · 0

    NO SAMPLE WAS AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED FOR THE PRODUCTION LOT AND FOUND ALL DOCUMENTATION WAS CONFORMING WITH WI-SGT-OP-007 (PICKING, VERIFICATION & PACKING OF KITS). PER PROCEDURE THE COMPONENTS ARE VERIFIED TO ENSURE THE PRODUCT IDENTIFICATION IS CORRECT, QUANTITY IS CORRECT, CONFIRM OVERALL SALABILITY (ENSURING PRODUCT IS IN GOOD CONDITION AND UNDAMAGED), AND VERIFY EXPIRATION MATCHES THE PRODUCT PACKING LIST FOR THE KIT. THE DEBRIS PRESENCE WAS NOTED AS BEING WITHIN THE SUPPLIED ACS KIDNEY CPT; THEREFORE, THIS INCIDENT WOULD NOT BE DETECTABLE BY THE SURGITRACK ASSEMBLY TEAM. THIS KIT IS SUPPLIED WITHIN A STERILE HEADER BAG SEALED UPON RECEIPT AND PLACEMENT BY THE O&M SURGITRACK ASSEMBLY TEAM. THERE WERE NO NONCONFORMANCES DOCUMENTED DURING PRODUCTION, OR ISSUES DOCUMENTED WHICH MAY CONTRIBUTE TO THIS INCIDENT. ALL INSPECTION CRITERIA WAS COMPLETED AND FOUND TO BE PASSING PER PRODUCTION RECORD DOCUMENTATION. ALL PRODUCT IS DE-CASED IN THE ANTE ROOM OR WAREHOUSE PRIOR TO PRODUCT ENTERING THE ASSEMBLY ROOM. HUMIDITY AND TEMPERATURE MONITORING PROCESSES ARE IN PLACE AT THE SURGITRACK ASSEMBLY SITE; HOWEVER, THESE WOULD NOT ATTRIBUTE TO THIS TYPE OF FAILURE. TEAMMATE PPE (GOWNS OR SCRUB REQUIREMENTS, INCLUDING HEAD COVERING AND SHOE COVER) PROCESS PROCEDURES ARE IN PLACE TO HELP MINIMIZE RISK OF DEBRIS INTRODUCTION TO ASSEMBLY ENVIRONMENT. CLEANING PROCEDURES (INCLUDING WIPING DOWN ASSEMBLY TABLES) IS ALSO PART OF PROCESS PROCEDURES. CLEANING RECORDS FOR LOT ASSEMBLY HAVE BEEN REVIEWED AND FOUND TO BE CONFORMING. THERE ARE NO OTHER DEBRIS RELATED COMPLAINTS DOCUMENTED WITHIN THE PAST YEAR FOR OWENS & MINOR DISTRIBUTION INC. OM44 SITE. NOTE: THE ACS KIDNEY CPT MANUFACTURING SITE CLOSED IN DECEMBER 2024 AND IS NO LONGER MANUFACTURING KITS. NO ACTIONS WILL BE TAKEN AT THIS TIME AS THIS APPEARS TO BE AN ISOLATED COMPLAINT INCIDENT. 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 FOREIGN MATERIAL THAT CONTAMINATED THE STERILE FIELD. THE PARTICLES LOOK LIKE SMALL PIECES OF CARDBOARD. THE FOREIGN MATERIAL FELL OUT OF KIDNEY CUSTOM PROCEDURE TRAY THAT WAS INCLUDED WITHIN SURGITRACK CONVENIENCE KIT. THE IMPACTED PATIENT WAS THE RECIPIENT OF A TRANSPLANT, THE PATIENT WAS IN CRITICAL CARE AND ON A PUMP. THE TIME-FRAME WAS LIMITED FOR WHEN THEY NEEDED TO HAVE PROCEDURE COMPLETED. THERE WAS A TWENTY MINUTE DELAY IN PROCEDURE AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646721 GENERAL SURGERY TRAY GENERAL SURGERY TRAY LRO OWENS & MINOR DISTRIBUTION, INC. 85C01770 16160-11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown