MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT CONNECTOR; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-16-1.7
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint product was not returned for evaluation.Root cause could not be determined.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 10 aug 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.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 complaint database and identified as complaint (b)(4).
Event or Problem Description
Avanos medical inc.Received a single report that referenced four different incidences, which were associated with the same unit, involving the same patient.This is the second of four reports.Refer to 9611594-2020-00145 for the first report.Refer to 9611594-2020-00147 for the third report.Refer to 9611594-2020-00148 for the fourth report.It was reported to the hospital by the patient's family that the overnight feed extension tubing had disconnected from the mic key feeding tube.This event occurred (b)(6) 2020.The patient was receiving continuous feed at night due to a glycogen storage disease type 1a, and had been hospitalized starting on (b)(6) 2020 due to hypoglycemia and seizure related to that condition.The tube had been placed on (b)(6) 2020.There was no injury to the patient.
Additional Manufacturer Narrative
All information reasonably known as of 27 aug 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 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 GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT CONNECTOR
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10388008
• Report Number: 9611594-2020-00146
• Device Sequence Number: 3447571
• Product Code: KNT
• UDI-Device Identifier: 00350770427454
• UDI-Public: 00350770427454
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2020

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: 8140-16-1.7
• 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: 07/24/2020
• Supplement Date Received by Manufacturer: 08/24/2020
• Initial Report FDA Received Date: 08/10/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1
• Patient Age: 10 MO
• Patient Weight: 13