MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NASOGASTRIC/NASOINTESTINAL PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT; DH CPK ANTI-IV (AIV) FEEDING TUBES

Model Number 40-8368

Device Problem Material Puncture/Hole (1504)

Patient Problem Pain (1994)

Event Date 08/24/2019

Event Type  malfunction  

Manufacturer Narrative

The product involved in the report has been returned and is being processed for evaluation.A review of the device history record is in-progress.Upon completion of the sample evaluation and investigation; a follow-up report will be filed.All information reasonably known as of 19-sep-2019 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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 the nasogastric (ng) tube blew up like a balloon and burst open when flushing with saline after medication administration.There were no reported patient injury.Additional information received 28-aug-2019 stated the ng tube became blocked.Two nurses attempted to unblock the ng tube with clog zapper and then warm water was used.When attempting to unblock the ng tube the device developed a bulge in the patient's esophagus, causing pain.The device was removed.The device was inserted on (b)(6) 2019 and was in use for 7-days.The user facilities protocol requires ng tubes to be flushed before and after feeding and all medications infusions with 5-10 ml flush each time.The patient remains in the hospital for treatment.No physical effects of incident were noted; however the patient needs another nasogastric tube inserted.

Manufacturer Narrative

The lot number reported by the customer was incorrect; therefore, a device history record could not be performed.One used sample was received.No product packaging was received.The product did not contain lot number identification.The device was evaluated and the failure was confirmed.A root cause was not identified.All information reasonably known as of 02-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.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 (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 PEDIATRIC FEEDING TUBE WITH STYLET WITH ENFIT
• Type of Device: DH CPK ANTI-IV (AIV) FEEDING TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 9089112
• MDR Text Key: 159356524
• Report Number: 9611594-2019-00180
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

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?: No
• Device Operator: Health Professional
• Device Model Number: 40-8368
• Device Catalogue Number: 104603702
• Device Lot Number: M142177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2019
• Initial Date FDA Received: 09/19/2019
• Supplement Dates Manufacturer Received: 11/08/2019
• Supplement Dates FDA Received: 12/03/2019
• Patient Sequence Number: 1
• Patient Age: 14 YR