MAUDE Adverse Event Report: AVANOS MEDICAL CORFLO; TUBE, GASTROINTESTINAL

Model Number 42-9225

Device Problems Break (1069); Contamination (1120); Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)

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

Event Date 09/07/2019

Event Type  malfunction  

Event Description

Following extubation of patient in the early am, the rn administered medication via the feeding tube with no resistance within the tube.Patient's feeds were restarted, but unable to flow due to obstruction in the feeding tube.Rn inquired with preceptor for guidance, at which time the preceptor attempted to flush feeding tube with sterile water but was unable to flush.Preceptor asked another nurse for help flushing the feeding tube.After multiple attempts of flushing, obstruction was cleared and rn's were able to obtain gastric content for ph testing to confirm placement.Team was consulted about continuing to feed patient despite tube no longer being transpyloric.Because the patient has metabolic disorder, the feeds could not be turned off for prolonged periods of time.Team agreed to continue gastric feeds.Patient tolerated gastric feeds.At 1600, chest x-ray revealed tube had snapped into two pieces.Patient was receiving gastric feeds, but the most distal part of the feeding tube was not connected to the proximal part of the tube and was also gastric.Team was notified and patient's feeds were stopped.Patient remained stable and provider ordered appropriate iv fluids for patient's metabolic needs.Feeding tube removed endoscopically and confirmed to be in two pieces.Feeding tube broken between marks 11 and 12, and the distal end of the feeding tube had a brown tint to it as noted by multiple rn's.

• Brand Name: CORFLO
• Type of Device: TUBE, GASTROINTESTINAL
• Manufacturer (Section D): AVANOS MEDICAL; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9346920
• MDR Text Key: 167152259
• Report Number: 9346920
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2019,10/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-9225
• Device Catalogue Number: 42-9225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 8 DA