MAUDE Adverse Event Report: AVANOS MEDICAL INC. UNKNOWN CATHETER; CATHETERS

Model Number UNKNOWN

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 22-sep-2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by a represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to a.Avanos medical, inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical, inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported the patient had a cut catheter tubing and taped it closely to the skin two days ago.The surgeon's physician assistant (pa) assessed the site and was unable to locate any residual catheter.There was no reported injury.Additional information received 07-sep-2021 via telephone stating the patient visited the office on friday, (b)(6) to have the site checked.The physician was unable to access the remainder of the catheter inside the operative site.During the time of telephone call the patient was in the process of being scheduled for removal of the remaining catheter.The pa stated that all patients are instructed about post-op care and proper removal of pump.The pa stated the patient decided to cut the catheter herself.

• Brand Name: UNKNOWN CATHETER
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12526158
• MDR Text Key: 273120005
• Report Number: 2026095-2021-00093
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/03/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1