BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENERAL SURGERY TRAY KIT

    MDR report key: 16513479 · Received March 9, 2023

    Report

    Report Number
    1047429-2023-00001
    Event Type
    Malfunction
    Date Received
    March 9, 2023
    Date of Event
    February 9, 2023
    Report Date
    April 24, 2023
    Manufacturer
    AVID MEDICAL
    Product Code
    LRO
    UDI-DI
    10809160315644
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. ALL INFORMATION REASONABLY KNOWN AS OF 09FEB2023 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. 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 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. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    CUSTOMER STATES SCALPELS ARE BREAKING IN TISSUE PROCUREMENT PACK. THERE WAS NO INJURY TO PATIENT OR HEALTHCARE PERSONNEL. THERE WAS NO INJURY WAS REPORTED TO EITHER PATIENT OR HEALTH CARE PERSONNEL. (THIS KIT IS USED FOR TISSUE PROCUREMENT FROM A DONOR).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659447 GENERAL SURGERY TRAY KIT PROCUREMENT PACK LRO AVID MEDICAL LLOG2000-13 1542772 10809160315644

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown