MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTRIC-JEJUNAL FEEDING TUBE KIT-ENDOSCOPIC/RADIOLOGIC PLACEMENT - 16 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	0250-16
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2019
Type of Reportable Event	Malfunction
Additional 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 11-apr-2019 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 or Problem Description
It was reported the "j" section of the gastrostomy tube broke and was retained in the patient's gastrointestinal tract.The broken end was excreted in the patient's feces.There was no reported injury.The device was inserted on (b)(6) 2018 and the procedure for this event was on (b)(6) 2019.
Additional Manufacturer Narrative
All information reasonably known as of 02-may-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.
Event or Problem Description
Additional information received 12-apr-2019 stated, it is was understood the procedure was a routine tube change.The device is changed every 3 to 4 months.No specific problems were noted.

• Brand Name: MIC GASTRIC-JEJUNAL FEEDING TUBE KIT-ENDOSCOPIC/RADIOLOGIC PLACEMENT - 16 FR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8509107
• Report Number: 9611594-2019-00079
• Device Sequence Number: 19145853
• Product Code: KNT
• UDI-Device Identifier: 10680651954807
• UDI-Public: 10680651954807
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K921370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2019

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: 0250-16
• Device Catalogue Number: 991095480
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/20/2019
• Supplement Date Received by Manufacturer: 04/12/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/02/2019
• Patient Sequence Number: 1
• Patient Age: 12 YR