MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ANGEL PRP KIT (US TRAY); PLATELET AND PLASMA SEPARATOR

Model Number	ARTHREX ANGEL PRP KIT (US TRAY)
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 07/01/2024, it was reported by a sales representative via (b)(4) that an abs-10061t arthrex angel® prp kit actual bag for the blood wouldn't connect within the centrifuge, and would not pull any blood up.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause can be attributed to user error due to improper insertion of the cassette.

• Brand Name: ARTHREX ANGEL PRP KIT (US TRAY)
• Common Device Name: PLATELET AND PLASMA SEPARATOR
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19783771
• Report Number: 1220246-2024-06824
• Device Sequence Number: 18171600
• Product Code: ORG
• UDI-Device Identifier: 00888867279919
• UDI-Public: 00888867279919
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: BK180180
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2025

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 Expiration Date: 11/30/2025
• Device Model Number: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Device Lot Number: 4060139210
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/01/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown