MAUDE Adverse Event Report: ARTHREX, INC. ANGEL CPRP PROCESSING SET USM; PLATELET AND PLASMA SEPARATOR

Model Number ANGEL CPRP PROCESSING SET USM

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 05/08/2023

Event Type  Injury  

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.

Event Description

On 5/9/2023, it was reported by a sales representative via sems that (2) abs-10063 cprp processing set, arthrex angel system, leaked blood out of the valve and did not produce prp.This was discovered during a procedure.The patient was not under general anesthesia.Per the sales representative, no one came in direct contact with the leaked blood.Additional information received on 5/11/2023: this was discovered during a hair treatment procedure.The procedure was not completed and had to be rescheduled.

• Brand Name: ANGEL CPRP PROCESSING SET USM
• 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: 17053066
• MDR Text Key: 316438081
• Report Number: 1220246-2023-06829
• Device Sequence Number: 1
• Product Code: ORG
• UDI-Device Identifier: 00888867084001
• UDI-Public: 00888867084001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110046
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ANGEL CPRP PROCESSING SET USM
• Device Catalogue Number: ABS-10063
• Device Lot Number: 2022110247
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/09/2023
• Date Device Manufactured: 11/01/2022
• 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
• Patient Outcome(s): Other