MAUDE Adverse Event Report: ARTHREX, INC. ARTHREX ACP DOUBLE SYRINGE SYSTEM; SYRINGE, PISTON

Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 10/25/2019

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 device was reported to have been discarded.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the acp double syringe system, abs-10010s, has an issue with blood leaking from an acp syringe while collecting the prp after the blood had been spun in the acp centrifuge.Instead of opening a new acp syringe, the account bailed to the arthrex angel prp system.They redrew blood from the patient, processed it with angel, and completed a successful injection.Additional information obtained on 11/07/2019: the blood leaked from the inner syringe as they began to separate the plasma from the rbc¿s.The blood was cleaned with caviwipes.The staff who was working with the device was gloved.The blood dripped onto a drape that covered the workspace.After the drape was as discarded, the space was cleaned with a caviwipe but the drape caught the spilled blood.One staff member reported that, even though they were gloved, blood spilled down their arm, which was uncovered and also, blood got on their scrub uniform.

• Brand Name: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Type of Device: SYRINGE, PISTON
• 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: vik bajnath ; 8009337001
• MDR Report Key: 9376339
• MDR Text Key: 168463865
• Report Number: 1220246-2019-01438
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK070069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/26/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2023
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 912193181
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/07/2019
• Initial Date FDA Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other