MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC GASTROSTOMY FEEDING TUBE WITH ENFIT® CONNECTORS - 16 FR; DH EF BALLOON TUBES PRODUCTS

Model Number	8100-16LV
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is reported to be available, but has not yet been received by the manufacturer.A review of the device history record is in-progress.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 halyard health complaint database and identified as complaint (b)(4).
Event or Problem Description
It was reported that during a bandage change, the feeding tube was severed, the balloon deflated, and "the probe fell." the bandage change had been done according to the hospital's process.The tube had been placed on (b)(6) 2019.No further information has been reported.
Additional Manufacturer Narrative
One used sample was returned for evaluation.Examination of the sample revealed signs of damage at the molded head of the device.There was a splitting under the molded head, in a part that would have been external to the patient's body.Examination under magnification revealed a non-jagged cut approximately 5mm left of the tubing at the bonded location where the molded head and tube are joined.The complaint is confirmed, however, no manufacturing related root cause could be determined.All information reasonably known as of 30 apr 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 halyard health 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 - 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: 8509111
• Report Number: 9611594-2019-00080
• Device Sequence Number: 16457164
• Product Code: KNT
• UDI-Device Identifier: 10680651442922
• UDI-Public: 10680651442922
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K842076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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 Expiration Date: 07/01/2021
• Device Model Number: 8100-16LV
• Device Catalogue Number: 104429200
• Device Lot Number: AA8211D20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 04/12/2019
• Supplement Report FDA Received Date: 05/01/2019
• Patient Sequence Number: 1