MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT CONNECTORS-22 FR; DH EF BALLOON TUBES PRODUCTS

Model Number 8100-22

Device Problem Use of Device Problem (1670)

Patient Problem Bruise/Contusion (1754)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.The device history record for the reported lot number, aa8176d17, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.All information reasonably known as of 09-jan-2019 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).

Event Description

It was reported the bumper on the tube was upside down.The clinician team did not note this and placed the device causing the "stoma site harm to the patient".Additional information received 02-jan-2019 stated the patient's stoma site was bruised and was not healing due to the bumper being placed upside down.Additional information received 03-jan-2019 stated the interventional radiology (ir) team placed a larger french device to adjust for the increase in the stoma site, allowing the site to heal.

Event Description

An fda medwatch mw5082361 was received 01-feb-2019.Additional information received 01-feb-2019 stating, "we encountered a tube (enfit 20f) that was delivered with the bumper on the tube upside down.Unfortunately the placement team did not catch this and placed the tube causing stoma site harm to the pt [patient].We reported this internally from our own reviews.

Manufacturer Narrative

All information reasonably known as of 15-feb-2019 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-22 FR
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8239337
• MDR Text Key: 133227581
• Report Number: 9611594-2019-00002
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10680651442953
• UDI-Public: 10680651442953
• Combination Product (y/n): N
• PMA/PMN Number: K842076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: 8100-22
• Device Catalogue Number: 104429500
• Device Lot Number: AA8176D17
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/01/2019
• Patient Sequence Number: 1