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

Model Number ARTHREX ACP DOUBLE SYRINGE SYSTEM

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2021

Event Type  malfunction  

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 (b)(6) 2021 it was reported by a distributor via sems that an abs-10010s double syringe leaked prp from plunger during injection.This was discovered during a prp therapy procedure, surgeon used a new double syringe to complete case.No patient affected.

Manufacturer Narrative

The complaint is not confirmed.One unpackaged abs-10010s was received for investigation.Visual and functional evaluation did not reveal any abnormality with the device.The device functioned as intended without disassembling and did not leak when tested with water.

• 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: 12576862
• MDR Text Key: 278210159
• Report Number: 1220246-2021-03749
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: BK070069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 0122103458
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/16/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1