MAUDE Adverse Event Report: AVANOS MEDICAL INC. MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 F; DH EF BALLOON TUBES PRODUCTS

Model Number	8140-14-3.0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record for the reported lot number, 30095962, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.The actual complaint product was not returned for evaluation.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
It was reported via fda medwatch / fda user facility report # mw (b)(4) the following: patient with new mickey gastr[ost]omy tube (gt) inserted today.Upon arrival and throughout shift-mickey button was in place, with three suture/buttons in place.Gauze was placed over the site-due to patient having anxiety when looking at new gt.Gauze with scant serosanguinous drainage noted.Gt venting.In evening- day and night rn handoff, lifted gown to find site was bleeding, one of the three buttons was completely detached, mickey button was completely out.Mickey balloon was found to be deflated.Md notified.Extra staff were called to bedside.Upon checking the balloon, the balloon was still completely intact.Unsure of where the fluid in the balloon could have gone as it was noted in the surgical note that is was inflated with 5ml sterile water.14 french 1.5cm gt kit at bedside, along with a 12 french rob-nel catheter.In accordance to advice from the gi fellow, the senior resident, reinserted a new mickey button.Patient was medicated prior to procedure with dilaudid pro re nata (prn) dose.There was no harm in this event.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE, EXTENSION SETS WITH ENFIT CONNECTORS - 14 F
• Common Device Name: DH EF BALLOON TUBES PRODUCTS
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12467741
• Report Number: 9611594-2021-00120
• Device Sequence Number: 4891846
• Product Code: KNT
• UDI-Device Identifier: 00350770427355
• UDI-Public: 00350770427355
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K043114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: User Facility
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 8140-14-3.0
• Device Catalogue Number: N/A
• Device Lot Number: 30095962
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 17 YR