MAUDE Adverse Event Report: ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A. ARM BOARD, IV, FLEXIBLE, 7.25" X 2", BLUE PURR, OUILOCK; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number	M8125-C
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A distributor complaint was received on 1/11/2023 reporting, "hello, we received complaints that the arm boards are abrasive and patients were being cut by them.We are unable to use these.Please provide return paperwork.Thank you." the sample has been requested for return but has not yet been returned to deroyal for evaluation at this time.This investigation is not complete at this time.No further information in available at this time.We will provide follow-up report once more information becomes available.
Event or Problem Description
"we received complaints that the arm boards are abrasive and patients were being cut by them.We are unable to use these.Please provide return paperwork.Thank you.".
Additional Manufacturer Narrative
The sample of the arm board was returned to deroyal on 01/19/2023 along with sample pictures.Deroyal conducted testing on these samples and found that none of the samples received were out of tolerance.Work orders, quality control inspection reports, labeling, and failure modes and effects analysis (fmea) were all checked and found to be acceptable.Root cause: no manufacturing issue has been found on the samples received by quality control manager.No changes have been made to the raw materials.It was found that the product returned by the customer was assembled as per requirements.Because no issue was found, there were no corrective and preventive actions taken.An inventory check of the tubing was made by deroyal, a total of 32 of the arm boards were inspected and no discrepancies were identified during the inspection.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, 7.25" X 2", BLUE PURR, OUILOCK
• Common Device Name: DEVICE, INTRAVASCULAR CATHETER SECUREMENT
• Manufacturer (Section D): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer (Section G): ORTHO & SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera; zona 3 finca; morancito, villa canales 01065 ; GT 01065
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19928775
• Report Number: 3010452421-2023-00001
• Device Sequence Number: 8082702
• Product Code: KMK
• UDI-Device Identifier: 50749756112487
• UDI-Public: 50749756112487
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: M8125-C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown