BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL SURGERY TRAY

    MDR report key: 19530258 · Received June 13, 2024

    Report

    Report Number
    3003419114-2024-00002
    Event Type
    Injury
    Date Received
    June 13, 2024
    Date of Event
    May 20, 2024
    Report Date
    September 18, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS
    Product Code
    OJG
    PMA / PMN Number
    EXEMPT
    Adverse Event
    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 WITHIN KIT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED, NO ANOMALIES OR CONTRIBUTING ISSUES WERE DOCUMENTED DURING MANUFACTURE. EVERY KIT FOR THIS CUSTOMER IS VERIFIED PRIOR TO STERILIZATION. THE SITE HAS A GOWNING PROCEDURE IN PLACE TO MINIMIZE CHANCE OF HAIR BEING INTRODUCED DURING ASSEMBLY PROCESS. BASED ON THE INVESTIGATION, IT WAS DETERMINED THAT ASSEMBLY OPERATORS DID NOT PAY ATTENTION TO DETAIL WHEN INSPECTING THE COMPONENTS ALLOWING A HAIR TO BE SENT TO THE CUSTOMER. ASSEMBLY OPERATORS WERE RETRAINED. ALL TEAMMATES HAVE BEEN MADE AWARE OF THE SERIOUSNESS OF THIS SITUATION. 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

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. 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. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    THERE WAS A LARGE, DARK HAIR FOUND ON OUR PACK OF LAPS THAT CAME IN THE CRANI PACK. THE PROCEDURE WAS DELAYED 15 MINUTES AS THE STERILE FIELD WAS REESTABLISHED WITH A NEW KIT SET UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766623 GENERAL SURGERY TRAY GENERAL SURGERY TRAY OJG AMERICAN CONTRACT SYSTEMS SLCN72F 910241

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other