MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN. X 17; CATHETERS

Model Number PM040-A

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is not possible as no lot number was provided.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 08 oct 2020 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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

Fill volume: unknown.Flow rate: unknown.Procedure: vat [video-assisted thoracoscopy].Cath.Place: between pleura and ribs.Infusion start time: unknown.Infusion stop time: unknown.It was reported that the tip broke off of a silver soaker catheter after difficult removal.The tip was retained in the patient, and is located "somewhere between pleura and ribs." the user facility is using the silver soaker catheters for pain treatment after vat operations.Patient was sent home to follow-up with physician at a later date.

Manufacturer Narrative

The device history record for lot 0002988387 was reviewed and the product was produced according to product specifications.All information reasonably known as of 06 nov 2020 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 avanos medical inc.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 avanos medical inc.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).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

Event Description

Additional information received 15-oct-2020 indicated that the retained portion of the catheter was removed from the patient and measured 28cm.

• Brand Name: ON-Q EXPANSION KITS WITH SILVERSOAKER CATHETER 10 IN (25 CM), NEEDLE 8 IN. X 17
• Type of Device: CATHETERS
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10655460
• MDR Text Key: 210911231
• Report Number: 2026095-2020-00123
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/06/2020

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 Expiration Date: 10/23/2021
• Device Model Number: PM040-A
• Device Catalogue Number: N/A
• Device Lot Number: 0002988387
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 11/06/2020
• Patient Sequence Number: 1