MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO; DH CPK NG TUBES

Model Number 42-9225

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.All information reasonably known as of 26-dec-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.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).

Event Description

It was reported an fda user facility report, #(b)(4), was received on 02-dec-2019, and the following information was provided: 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.Patient remained stable and was discharged on (b)(6) 2019.

Manufacturer Narrative

Correction: d4.All information reasonably known as of 31-jan-2020 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 avanos medical, inc.Complaint database and identified as complaint comp-(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: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTO
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9523215
• MDR Text Key: 196954749
• Report Number: 9611594-2019-00258
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K831328
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 02/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 42-9225
• Device Catalogue Number: 991046085
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 8 DA