MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 14 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 8100-14LV

Device Problems Material Puncture/Hole (1504); Migration (4003)

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

Event Date 06/01/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 19 jul 2021 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

It was reported that the gastrostomy probe was placed on (b)(6) 2021.On (b)(6) 2021, a scan was performed which showed a migration of the probe.After removal of the tube the balloon was found to be pierced.No patient injury was noted.Additional information received (b)(6) 2021 indicated that the tip of the probe was located outside the stomach; physician confirmed it was a peritoneal migration.The anchors were still in place.The patient's condition "was not altered" and a new probe was placed.Additional information has been requested but not yet received.

Manufacturer Narrative

The device history record for lot 30085556 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The molded head, tube, and balloon appear to have slight discoloration on the exterior and interior of the device.The device could not be filled with the suggested amount of water due to an apparent axial splitting of the balloon fabric.The split is extending from the base of the balloon to the distal tip of the device.The balloon material was inspected under magnification (20x) and a notch/tab was identified in the medial location of the balloon material.The root cause of the reported incident could not be conclusively determined.All information reasonably known as of 16 aug 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 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.

• Brand Name: MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS - 14 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12189043
• MDR Text Key: 262256776
• Report Number: 9611594-2021-00097
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770442914
• UDI-Public: 00350770442914
• Combination Product (y/n): N
• PMA/PMN Number: K842076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2023
• Device Model Number: 8100-14LV
• Device Catalogue Number: N/A
• Device Lot Number: 30085556
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 55