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 Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2016

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.

Event Description

It was reported that the inner seal of the abs10010s (lot 715674659) was not sealed correctly and prp leaked.Additional information obtained 6/25/20: the procedure took place sometime in 2016 at the surgeons office.The procedure was an ankle injection.The leakage did contain bodily fluid and the fluid leaked onto/from the tip of the syringe.The device was disposed of at the time of procedure.Specific date of procedure in 2016 is unknown.(b)(6) 2016 will be entered as a date of occurrence.

• 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: 10218377
• MDR Text Key: 197211693
• Report Number: 1220246-2020-01942
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867083790
• UDI-Public: 00888867083790
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK070069
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: ARTHREX ACP DOUBLE SYRINGE SYSTEM
• Device Catalogue Number: ABS-10010S
• Device Lot Number: 715674659
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2017
• 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