BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD CLEANING & CUTTING TRAY

    MDR report key: 16701832 · Received April 7, 2023

    Report

    Report Number
    1047429-2023-00002
    Event Type
    Malfunction
    Date Received
    April 7, 2023
    Date of Event
    March 7, 2023
    Report Date
    April 25, 2023
    Manufacturer
    AVID MEDICAL
    Product Code
    LRO
    UDI-DI
    10809160339633
    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 REPORT IS NOT AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 07APR2023 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 0

    A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED AS THE DEFECT DEVICE WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. THE SCALPEL MANUFACTURER NIRAJ INDUSTRIES PVT. LTD WAS MADE AWARE OF THIS ISSUE. THE COMPLAINT COMPONENT 5311876 SCALPEL WAS A SUBSTITUTION FOR THE REGULAR SCALPEL INCLUDED IN THE CUSTOMER CONVENIENCE KIT. AVID MEDICAL PERFORMED AN INSPECTION WHICH FOUND THAT THE THIS SUBSTITUTE SCALPEL WAS BENDABLE NEAR THE MIDDLE WHERE THE CUSTOMER EXPERIENCED BREAKING AND THE BLADE IS SLIGHTLY MORE NARROW THAN THE ONE THE CUSTOMER WAS ACCUSTOMED TO. THIS COMPONENT WILL NO LONGER BE PROVIDED AS A SUBSTITUTION FOR THE CUSTOMER'S PREFERRED SCALPEL COMPONENT WITHIN THIS CONVENIENCE KIT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. 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 O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    AVID MEDICAL RECEIVED A COMPLAINT ON 03/10/23 ORIGINATED BY 1047429-2023-00002 STATING THAT SCALPELS IN OUR PROCUREMENT PACKS ARE BREAKING IN THE MIDDLE OF THE SCALPEL DUE TO BRITTLE HANDLES. NO INJURY WAS REPORTED TO EITHER PATIENT OR HEALTH CARE PERSONNEL. THIS KIT IS USED FOR TISSUE PROCUREMENT FROM A DECEASED DONOR. AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY - REF LLOF1500-15 CLEANING & CUTTING TRAY THAT INCLUDES THE FOLLOWING COMPONENT: SCALPEL #21 DISPOSABLE, VENDOR REF 6000CST-21 SUPPLIED BY MYCO MEDICAL SUPPLIES INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730600 HALYARD CLEANING & CUTTING TRAY GENERAL SURGERY TRAY (KIT) LRO AVID MEDICAL LLOF1500-15 1542740 10809160339633

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown