MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY CONTINUOUS FEED EXTENSION SET WITH ENFIT CONNECTORS, SECUR-LOK; DH EF BALLOON TUBES PRODUCTS

Model Number 0141-12

Device Problem Disconnection (1171)

Patient Problem Hypoglycemia (1912)

Event Date 03/21/2019

Event Type  Injury  

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 02 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.Device not returned.

Event Description

It was reported by the patient's parents that their son, who has type 1a glycogenosis, woke up screaming and in a state of convulsion.The child's blood sugar was 0.18.They found that the extension set attached to the continuous feed had broken away from the gastric button at some point in the night.They called emergency services.Per additional information received 27 mar 2019, there was no need for surgery.The patient is back to the same status he was prior to the incident.The parents report that there was no visible defect to the extension set.The continuous feeding machine that was used during the incident was a nutricia flocare infinity, and the device was working normally and does not alarm when the feed leaks on to the bed.

Manufacturer Narrative

All information reasonably known as of 21 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 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-KEY CONTINUOUS FEED EXTENSION SET WITH ENFIT CONNECTORS, SECUR-LOK
• Type of Device: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 8486606
• MDR Text Key: 141029785
• Report Number: 9611594-2019-00064
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 20680651440666
• UDI-Public: 20680651440666
• Combination Product (y/n): N
• PMA/PMN Number: K993138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/01/2021
• Device Model Number: 0141-12
• Device Catalogue Number: 104418100
• Device Lot Number: AA8302C03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 3 YR