BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVENTIONAL TRAY

    MDR report key: 21436894 · Received February 21, 2025

    Report

    Report Number
    1047429-2025-00002
    Event Type
    Injury
    Date Received
    February 21, 2025
    Date of Event
    January 16, 2025
    Report Date
    March 26, 2025
    Manufacturer
    AVID MEDICAL, INC.
    Product Code
    LRO
    UDI-DI
    10809160348895
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INCIDENT TWO OF TWO: THE PRODUCT INVOLVED IN THE EVENT WAS NOT RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. 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 CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    INCIDENT TWO OF TWO. NO SAMPLES WERE AVAILABLE FOR EVALUATION. THE PRODUCT WAS INSPECTED PER ANSI/ASQ Z1,4: LEVEL S-3 AQL 1.5. 120 TRAYS WERE BUILT AND 8 TRAYS WERE INSPECTED WITH NO DEFECTS FOUND. NO ADDITIONAL HANDLING WAS DOCUMENTED DURING MANUFACTURE. STERILIZATION DOCUMENTATION WAS REVIEWED TO ENSURE ALL PARAMETERS WERE WITHIN VALIDATED STERILIZATION REQUIREMENTS. NO ABNORMALITIES WERE FOUND. HEADER BAG SEALER CALIBRATION WAS CONFIRMED TO BE CURRENT. PULL AND CREEP FUNCTIONAL TEST RESULTS WERE REVIEWED FROM MANUFACTURE, ALL RESULTS WERE WITHIN SPECIFICATION. CLEANING RECORDS DURING MANUFACTURE WERE CONFIRMED TO BE CURRENT WITH NO NOTED ISSUES. THE SITE DOES HAVE DEFINED PROCESSES IN PLACE TO MINIMIZE OPPORTUNITY FOR CONTAMINATION. THESE INCLUDE: GOWNING PROCEDURES, ENVIRONMENTAL AND BIOBURDEN MONITORING. NO ABNORMALITIES WERE FOUND. THIS KIT LOT WAS BUILT WITHOUT TYPICAL EXIDINE, CHG 4OZ. 2% FLIP TOP THAT IS USED BY END-USER TO CLEAN THE SKIN DURING SURGICAL PREP. THE LABEL INDICATED THIS COMPONENT WAS NOT INCLUDED. THE CUSTOMER HAS CONFIRMED THAT THEY USED DYNA-HEX 4 CHG ANTISEPTIC IN PLACE FOR THE PATIENT. A COMPLAINT TRENDING ANALYSIS WAS PERFORMED FOR COMPLAINTS SINCE 2021, HISTORICALLY THERE ARE NO SIMILAR COMPLAINTS. 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 CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    INCIDENT TWO: PATIENT WAS REPORTED TO HAVE A POST-SURGICAL INFECTION. THERE WAS MEDICAL INTERVENTION (ANTIBIOTICS) PROVIDED FOR THIS PATIENT. ADDITIONAL INFORMATION WAS REQUESTED ON FEBRUARY 6, 2025, FEBRUARY 11, 2025, AND FEBRUARY 17, 2025, THE SITE IS CURRENTLY AWAITING FURTHER DETAILS INCLUDING DETAILS OF THE TYPE OF INFECTION, TYPE OF PROCEDURE, AND TECHNIQUE UTILIZED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511958 INTERVENTIONAL TRAY INTERVENTIONAL TRAY LRO AVID MEDICAL, INC. PSSC004 1629088 10809160348895

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other