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 Obstruction of Flow (2423)

Patient Problem Insufficient Information (4580)

Event Date 10/17/2023

Event Type  malfunction  

Event Description

On 10/17/2023, it was reported by a sales representative via sems-06058920 that an abs-10061t prp kit would not drain the blood.This occurred during use.The blood stayed inside the cassette they had to spin it manually.

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.

• 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: 18101893
• MDR Text Key: 328428793
• Report Number: 1220246-2023-08636
• 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: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• 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: 3198133413
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2022
• 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