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
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 four 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.
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 four 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.

• 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: 25003088
• Report Number: 3010452421-2026-00004
• Device Sequence Number: 9774155
• 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: 61689711
• 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