BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENERAL SURGERY TRAY

    MDR report key: 19387904 · Received May 23, 2024

    Report

    Report Number
    3003309947-2024-00001
    Event Type
    Injury
    Date Received
    May 23, 2024
    Date of Event
    April 15, 2024
    Report Date
    July 1, 2024
    Manufacturer
    AMERICAN CONTRACT SYSTEMS, INC
    Product Code
    LRO
    UDI-DI
    00191072210838
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. 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. ACS TAMPA CONDUCTED A REVIEW OF THE ASSEMBLY RECORDS ASSOCIATED WITH THE DISCREPANT PACK AND DID NOT OBSERVE ANY CITED EVENTS THROUGHOUT THE BUILD. AS THE ISSUE CONCERNED FOREIGN MATTER, ACS OPERATIONS ALSO REVIEWED ITS CURRENT ENVIRONMENTAL/GOWNING PROCEDURE TO ENSURE THE PRODUCTION TEAM IS CONTINUING TO EXERCISE PROPER GOWNING TECHNIQUES AND RAISING AWARENESS IF FOREIGN MATTER IS FOUND DURING PRODUCTION. DUE TO THE LIMITED DETAILS PROVIDED IN THE COMPLAINT, ACS CANNOT DETERMINE THE ORIGIN/ROOT CAUSE OF THE HAIR PRESENCE IN THE PACK. MANUFACTURING WAS COMPLETED IN ACCORDANCE WITH STATED PROCEDURES. HOUSEKEEPING RECORDS REFLECT PROPER ENVIRONMENTAL CONTROLS TO INCLUDE COMPLIANCE WITH THE STANDARD GOWNING PROCEDURE. A ROOT CAUSE WAS NOT DETERMINED. 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

    A HAIR WAS FOUND IN THE PROCEDURE PACK ON (B)(6) 2024. THE PROCEDURE WAS A NEUROSPINE CASE. THE HAIR WAS DISCOVERED IN THE OR. THE INCIDENT CONTAMINATED THE SURGICAL FIELD RESULTING IN REPORTED PROCEDURE DELAY. THE COMPLAINT SITE WAS ASKED ADDITIONAL IMPACT QUESTIONS ON (B)(6) 2024, (B)(6) 2024. THE COMPLAINT SITE HAS NOT RESPONDED TO THESE INQUIRIES TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054876 GENERAL SURGERY TRAY GENERAL SURGERY TRAY LRO AMERICAN CONTRACT SYSTEMS, INC 929241 00191072210838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown