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
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	10/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual sample was not returned for further evaluation of the potential defect; however, a photograph of the device was provided.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 13-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 or Problem Description
It was reported tube completely broken off inside of the patient.The patient had to go to endoscopy and the gastro-intestinal (gi) doctor performed a procedure and retrieved the broken device.Additional information received 27-oct-2020 stated the patient's mother, a registered nurse, reported the devices had a malfunctioning gastric port, with reflux.The patient's mother heard a popping noise while injecting into the tube on the prior evening.A wire was inserted, and the button portion of the device was removed.At the time of the event the tube transected, approximately 35cm from the proximal duodenum to the jejunum.The wire left in place, the was patient transferred to endoscopy for retrieval of distal portion of tube.The patient was returned to imaging and new device was placed.
Additional Manufacturer Narrative
Correction a2: age 27-years old.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
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10845205
• Report Number: 9611594-2020-00228
• Device Sequence Number: 2904577
• Product Code: KNT
• UDI-Device Identifier: 00350770956756
• UDI-Public: 00350770956756
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K926581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/24/2020
• Initial Report FDA Received Date: 11/16/2020
• Supplement Report FDA Received Date: 12/21/2020
• Patient Sequence Number: 1
• Patient Age: 27 YR