BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-LINE

    MDR report key: 8595227 · Received May 9, 2019

    Report

    Report Number
    1047429-2019-00007
    Event Type
    Injury
    Date Received
    May 9, 2019
    Date of Event
    April 12, 2019
    Report Date
    May 9, 2019
    Manufacturer
    ACCU-LINE PRODUCTS INC.
    Product Code
    FZZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AVID MEDICAL IS THE MANUFACTURER OF A CUSTOM PROCEDURE TRAY REF: STVA014-04, CUSTOM KNEE ARTHROSCOPY, THAT INCLUDES THE FOLLOWING COMPONENT: MARKER, SKIN RULER & 6 LABELS, VENDOR PART # P-1RLNS MANUFACTURED BY ACCU-LINE PRODUCTS INC. AVID MEDICAL RECEIVED A COMPLAINT ON 04/19/19 ORIGINATED BY PHIL MORAN, DEPUTY FACILITY CHIEF SUPPLY CHAIN OFFICER, OF ST. CLOUD VA HEALTH CARE SYSTEM. THE COMPLAINT STATES THAT DURING A KNEE ARTHROSCOPY PROCEDURE, THE MEDICAL TEAM OBSERVED ON THE MONITOR SCREEN PURPLE "FLOATERS" OR FLAKES BELIEVED TO BE FROM THE SKIN MARKER IN DIRECT CONTACT WITH THE SURGICAL WOUND. THE SURGEON USES THE SKIN MARKER TO INDICATE THE INCISION LINE. THE COMPLAINT COMPONENT WAS NOT AVAILABLE FOR FURTHER EVALUATION. AVID MEDICAL ISSUED FORMAL COMPLAINT # (B)(4) TO THE MANUFACTURER ACCU-LINE PRODUCTS INC CONCERNING THE FLAKING OF THE SKIN MARKER FOR ITEM# P-1RLNS, MFG LOT# 80109. HOWEVER, AVID MEDICAL DISCOVERED THE SITE HAS SINCE WENT OUT OF BUSINESS. NO PATIENT INJURY WAS REPORTED. THE MEDICAL TEAM STATED THAT "WE IRRIGATED THE WOUND THOROUGHLY.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390971 ACCU-LINE SURGICAL MARKING SYSTEM FZZ ACCU-LINE PRODUCTS INC. P-1RLNS 80109

    Patients

    Seq Age Sex Outcome Treatment
    1 Other