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

Model Number ARTHREX ANGEL PRP KIT (US TRAY)

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 06/02/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via email that an abs-10061t arthrex angel prp kit tubing was loose, and blood leaked.Also, the ar-160060 angel centrifuge wiring was loose.This was discovered during a procedure.Additional information received on (b)(6) 2023: this was discovered during a prr injection procedure on (b)(6) 2023.The patient was not under general anesthesia.The case was completed using a new ar-160060 angel centrifuge and an abs-10010s arthrex acp double syringe system.

Manufacturer Narrative

The contribution of the device to the reported event has not yet been determined as the device has not been returned for evaluation at this time.A follow-up report will be submitted, including a most likely cause if a root cause can not be determined.

• Brand Name: ARTHREX ANGEL PRP KIT (US TRAY)
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17190111
• MDR Text Key: 317783112
• Report Number: 1220246-2023-06968
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867279919
• UDI-Public: 00888867279919
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK180180
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARTHREX ANGEL PRP KIT (US TRAY)
• Device Catalogue Number: ABS-10061T
• Device Lot Number: 2346127512
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/02/2023
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1