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

Model Number ACP KIT SERIES I

Device Problems Fluid/Blood Leak (1250); Defective Device (2588); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2021

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 sale representative via sems that an abs-10011 acp kit series i, is faulty and leaked.Additional information 9/27/2021 on (b)(6) 2021 it was reported by a sale representative via sems that an abs-10011 acp kit series i, flange part on the inner syringe did not have a good seal and acp was leaking out of the back while the doctor pushed the plunger to inject.This was discovered during a prp injection on (b)(6) 2021.The prp injection was completed by opening and additional kit and redraw.

• 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: 12569496
• MDR Text Key: 278221419
• Report Number: 1220246-2021-03724
• 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: 10/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: ACP KIT SERIES I
• Device Catalogue Number: ABS-10011
• Device Lot Number: 1091111237
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2021
• Date Device Manufactured: 05/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1