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

Model Number	ARTHREX ACP DOUBLE SYRINGE SYSTEM
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2020
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
It was reported that the abs-10010s prp kit seemed to be faulty during use.As the physician was trying to use the device for an injection, it continuously leaked out of the top of the syringe as they were trying to inject.The physician stated there were injecting under pressure (into spaces with resistance / not much tissue).Additional information obtained 11/4/20: the fluid leaked out of the top of the syringe, which was how it was first noticed that something was off.It came between the plunger and the seal of the syringe.Fluid leaked onto staff member's hand and the staff member though perhaps they had squirted it between injections.This occurred after the syringe was spun.I came into contact with the staff member's gloved hand and nothing else.The gloves were changed and the surface on the floor underneath was cavi-wiped.The patient was receiving injections into his dermis around his scalp for the treatment of psoriasis and damage from excessive corticosteroid treatment.The procedure was performed in the surgeon's clinic and the procedure was not completed.Injections were ceased once the fluid leak was understood.Patient injections were continued in 2 weeks and patient was monitored for sign of infection as per their usual procedure after injections.The same lot number was used in the subsequent session.

• Brand Name: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10843320
• Report Number: 1220246-2020-02340
• Device Sequence Number: 19740249
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK070069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 926197305
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/16/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other