MAUDE Adverse Event Report: ARTHREX, INC. REDEUCE TUBING SYSTEM; ARTHROSCOPE

Catalog Number AR-6411

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/22/2020

Event Type  malfunction  

Event Description

Arthrex pump tubing was found to have a cut in the tubing when the rn primed the tubing prior to the case.Tubing was marked with tape right at the cut.(b)(6).Fda safety report id# (b)(4).

• Brand Name: REDEUCE TUBING SYSTEM
• Type of Device: ARTHROSCOPE
• Manufacturer (Section D): ARTHREX, INC.
• MDR Report Key: 11385126
• MDR Text Key: 234071984
• Report Number: MW5099661
• Device Sequence Number: 1
• Product Code: HRX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AR-6411
• Device Lot Number: 44187917
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1