MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTRIC-JEJUNAL FEEDING TUBE KIT - 22 FR, 3.0 CM - 45 - NON-ENFIT; DH EF BALLOON TUBES PRODUCTS

Model Number 0270-22-3.0-45

Device Problem Material Puncture/Hole (1504)

Patient Problem Vomiting (2144)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 18-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).

Event Description

It was reported one device had a small hole just below the balloon so when feeding in jejunal port it came out g-port.Additional information received 27-oct-2020 stated the patient was vomiting with tube feedings.A kidneys, urethra and bladder (kub) x-ray noted the device was in proper placement.The device was replaced.The removed device noted a clogged small pin hole below the balloon on the jejunal side of the device.

Manufacturer Narrative

The investigation concluded that without a sample functional evaluation could not be performed in order to confirm or duplicate the reported incident.A root cause could not be determined.All information reasonably known as of 18-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).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 GASTRIC-JEJUNAL FEEDING TUBE KIT - 22 FR, 3.0 CM - 45 - NON-ENFIT
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10864184
• MDR Text Key: 222019880
• Report Number: 9611594-2020-00229
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00350770956756
• UDI-Public: 00350770956756
• Combination Product (y/n): N
• PMA/PMN Number: K926581
• 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: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0270-22-3.0-45
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Patient Sequence Number: 1
• Patient Age: 27 YR