MAUDE Adverse Event Report: ARTHREX, INC. ACP KIT SERIES I; SYRINGE, PISTON

Model Number ACP KIT SERIES I

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 02/23/2023

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 02/23/2023, it was reported by sales representative via sems that an abs-10011 acp® kit had blood leaking out.This occurred during a case when blood started leaking out, the kit was thrown away.The case was completed using a new kit.There was no patient effect reported.

• Brand Name: ACP KIT SERIES I
• 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: 16552670
• MDR Text Key: 311702296
• Report Number: 1220246-2023-06433
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867001824
• UDI-Public: 00888867001824
• 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: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 2307126641
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/23/2023
• Date Device Manufactured: 12/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1