BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARM BOARD, IV, FLEXIBLE, 4" X 9", BLUE PURR, OUILOCK 

    MDR report key: 25003142 · Received April 27, 2026

    Report

    Report Number
    3010452421-2026-00006
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 11, 2026
    Manufacturer
    ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.
    Product Code
    KMK
    UDI-DI
    00749756112475
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES. SEVEN COMPLAINTS WERE REPORTED WITH THIS ISSUE. THIS IS REPORT SIX OF SEVEN. DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS STATED AS UNAVAILABLE FOR RETURN. SAMPLES WERE RETURNED FROM OTHER COMPLAINTS OF A SIMILAR ISSUE AND REVIEWED. DEROYAL REVIEWED THE DEVICE HISTORY RECORD FOR THE DEVICES AND NO ISSUES WERE FOUND. THE QUALITY CONTROL INSPECTION REPORTS WERE ALSO REVIEWED AND ALL WERE FOUND TO BE ACCEPTABLE. NO ISSUES WERE FOUND FOR "YELLOWISH MATERIAL." AN INVENTORY CHECK WAS PERFORMED ON 480 UNITS AT DEROYAL DISTRIBUTION. FIVE UNITS OF THOSE INSPECTED WERE FOUND TO HAVE YELLOW SHADES. THIS WAS BELOW THE LOT REJECTION RATE OF 11 UNITS FOR LOTS CONTAINING MORE THAN 315 UNITS. A COMPLAINT TO SALES RATIO WAS CONDUCTED FROM JANUARY 2024 THROUGH MAY 2026 AND FOUND TO BE (B)(4). ROOT CAUSE: BASED ON THE INVESTIGATION PERFORMED, IT WAS DETERMINED THAT TWO ISSUES CAN CONTRIBUTE TO THIS TYPE OF DISCOLORATION: AGE OF MATERIAL AND LIGHT EXPOSURE. THEREFORE, THE ROOT CAUSE WAS DETERMINED TO BE OXIDATION OF THE FOAM AS IT AGES OR IS EXPOSED TO LIGHT. CORRECTIVE OR PREVENTIVE ACTIONS: BECAUSE THE FAILURE MODE DOES NOT HAVE ANY EFFECT ON THE PATIENT, NO CORRECTIVE OR PREVENTIVE ACTIONS HAVE BEEN TAKEN AT THIS TIME. DEROYAL WILL CONTINUE TO MONITOR FOR TRENDS AROUND THIS ITEM AND ISSUE. THIS INVESTIGATION IS COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES. SEVEN COMPLAINTS WERE REPORTED WITH THIS ISSUE. THIS IS REPORT SIX OF SEVEN. DEROYAL INDUSTRIES, INC. REQUESTED RETURN OF THE DEVICE, HOWEVER IT WAS STATED AS UNAVAILABLE FOR RETURN. THIS INVESTIGATION IS NOT COMPLETE AT THIS TIME. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. WE WILL PROVIDE FOLLOW-UP REPORT WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A USER FACILITY REPORTED ON AN FDA MEDWATCH, "YELLOWISH COLOR." THIS WAS FOUND PRIOR TO USE AND DID NOT CAUSE ANY INJURIES OR OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56464 ARM BOARD, IV, FLEXIBLE, 4" X 9", BLUE PURR, OUILOCK  DEVICE, INTRAVASCULAR CATHETER SECUREMENT KMK ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. M8125-A 62242849 00749756112475

    Patients

    Seq Age Sex Outcome Treatment
    1