MAUDE Adverse Event Report: AVANOS MEDICAL, INC. AVANOS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Device Problems Break (1069); Crack (1135); Flushing Problem (1252); Leak/Splash (1354); Obstruction of Flow (2423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2020

Event Type  No Answer Provided  

Event Description

Patient had a gastrostomy-jejunostomy mic-key button g-tube placed.Three weeks later, this nurse got report from night nurse that the jejunostomy connection piece had broken.The connection was leaking during feeds as well as cracked.The nurse tried to trouble shoot it but eventually a piece broke off.She notified overnight doctor.In the morning i trouble shooted it.The leur-lock connected still with a syringe but not that well.It was then clogged and would not flush.The team was notified and patient went to ir that afternoon to have a new tube placed.Doctor had trouble getting the j part of the catheter in.Patient came back with only new gastric tube x2 ports instead of a j tube and g-tube port.Per mom the original g-j tube had been leaking for a week per the nurses and finally broke.Mom was frustrated that tube had to be replaced and that it wasn't looked at earlier before it broke.

• Brand Name: AVANOS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10028317
• MDR Text Key: 189996145
• Report Number: 10028317
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/06/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4015 DA