MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK; DH EF BALLOON TUBES PRODUCTS

Model Number 0620-20-4.5

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Code Available (3191)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 21 dec 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).

Event Description

It was reported that "water leaked from balloon and the tube came out from the patient's stoma.The patient's stoma was closed and gastrostomy operation will be performed." additional information received 17-dec-2020 indicated the tube was out of the patient's stoma for approximately one month.No attempt was made to place the feeding tube back into the stoma site.Additional information has been requested but not yet received.

Manufacturer Narrative

Upon further clinical review, it has been determined that the reported event is not a malfunction that could lead to serious injury.New tube placement requires a new procedure and is not a reportable event.All information reasonably known as of 19 jan 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-KEY LOW-PROFILE GASTROSTOMY FEEDING TUBE WITH SECUR-LOK
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11049526
• MDR Text Key: 223168411
• Report Number: 9611594-2020-00249
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K993138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0620-20-4.5
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other