MAUDE Adverse Event Report: AVANOS MEDICAL INC. INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR; DH EF PERC PLACEMENT PRODUCTS

Model Number 98430

Device Problem Break (1069)

Patient Problem Abdominal Distention (2601)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device history record for lot aa9189r03 was reviewed and the product was produced according to product specifications.The actual complaint product was not returned for evaluation.Root cause could not be determined.All information reasonably known as of 12 aug 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.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 that two of the three gastropexy sutures had fallen off by day four post-insertion.Day 1 post review, abdominal distention was noted.The final suture fell out by day 8.Additional information received 2020-07-27 indicated there was no patient injury and no need for medical intervention or treatment.Patient's current condition was listed as "no concerns, functional rig [radiologically inserted gastrostomy] tube.".

• Brand Name: INTRODUCER KIT FOR GASTROSTOMY FEEDING TUBE, 16FR DILATOR
• Type of Device: DH EF PERC PLACEMENT PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• Manufacturer (Section G): AVENT SA DE R.L. DE C.V. (AVENT 1); circuito industial no.40; colonia obrera; nogales, cp 84048 ; MX 84048
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 10399033
• MDR Text Key: 203138093
• Report Number: 9611594-2020-00154
• Device Sequence Number: 1
• Product Code: KGC
• UDI-Device Identifier: 00350770984308
• UDI-Public: 00350770984308
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 98430
• Device Catalogue Number: N/A
• Device Lot Number: AA9189R03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2019
• 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
• Patient Age: 67 YR
• Patient Weight: 97