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

Model Number	ARTHREX ACP DOUBLE SYRINGE SYSTEM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) /2022, it was reported by a sales representative via sems that an abs-10010s arthrex acp® double syringe system had an issue.The syringe/plunger pulled out causing blood to leak from the syringe.Another syringe was used successfully and there was no harm to the patient.The device was discarded as it had blood on it.This was discovered during use on (b)(6) 2022 with no impact to the patient.Additional information has been requested.On (b)(6) 2022, the sales representative stated the following information over the phone: this event occurred during a prp procedure.Neither the patient nor the facility staff was harmed, and even though it was not specified how the area was decontaminated, they were following a standard decontamination procedure, and another syringe then was used to complete the procedure successfully.No anti-coagulant was used, and it was not specified if air bubbles were observed during the blood draw.
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.If the device becomes available for evaluation, a follow-up report will be submitted.

• Brand Name: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Common Device Name: 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: 15484391
• Report Number: 1220246-2022-05547
• Device Sequence Number: 20147583
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: BK070069
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 830587646
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 09/26/2022
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown