MAUDE Adverse Event Report: AVANOS MEDICAL, INC. MIC-KEY GASTROSTOMY FEEDING TUBE; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Lot Number 30178188 & 30181451

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

Patient Problem Insufficient Information (4580)

Event Date 04/07/2022

Event Type  malfunction  

Event Description

Avanos mic-key gastrostomy feeding tube 14 french 1.2 cm (lot 30178188) was sterilely opened to the field.Upon testing inflation of the balloon with sterile water, it was found that the balloon was perforated.Avanos mic-key gastrostomy feeding tube 14 french 1.2 cm (lot 30181451) was opened to the sterile field and was found to also have a hole in the balloon.Both were not used.

• Brand Name: MIC-KEY GASTROSTOMY FEEDING TUBE
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14851008
• MDR Text Key: 294939847
• Report Number: 14851008
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 30178188 & 30181451
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 90 DA
• Patient Sex: Male