MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. ARM BOARD, IV, FLEXIBLE, 4" X 9", BLUE PURR, OUILOCK ; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	M8125-A
Medical Device Problem Code	Unexpected Color (4055)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
A user facility reported on an fda medwatch, "yellowish color." this was found prior to use and did not cause any injuries or outcomes.
Additional Manufacturer Narrative
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 seven 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.

• Brand Name: ARM BOARD, IV, FLEXIBLE, 4" X 9", BLUE PURR, OUILOCK
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera a villa; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: reagan facemire ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 25003149
• Report Number: 3010452421-2026-00007
• Device Sequence Number: 21303493
• Product Code: KMK
• UDI-Device Identifier: 00749756112475
• UDI-Public: 00749756112475
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M8125-A
• Device Lot Number: 62311939
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown