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

Model Number ACP KIT SERIES II

Device Problems Fluid/Blood Leak (1250); Misconnection (1399)

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

Event Date 12/20/2021

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 sales representative via email that an abs-10012 acp kit had to be discarded because during the spin, the syringes were not fully connected and the patients blood started to spill out of the large string into the centrifuge chamber.A new kit was opened and procedure was completed successfully without further issues.

• Brand Name: ACP KIT SERIES II
• 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: 13225554
• MDR Text Key: 285835188
• Report Number: 1220246-2022-04264
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00888867001831
• UDI-Public: 00888867001831
• 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: 01/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: ACP KIT SERIES II
• Device Catalogue Number: ABS-10012
• Device Lot Number: 1123112093
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2021
• Date Device Manufactured: 06/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1