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

Model Number	20-9225AIV2
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/29/2018
Type of Reportable Event	Malfunction
Additional 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 (b)(6) 2018 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).
Event or Problem Description
It was reported the tip was coming off of the nasogastric (ng) tube.Additional information received 01-aug-2018 stated the tip of the feeding broke off inside of the patient.Additional information received 08-aug-2018 stated that on (b)(6) 2018 the tube was placed in the right patient's nare, measuring to the 24cm mark.The nurse was unable to obtain aspirate for ph confirmation and a kidneys-urethra-bladder (kub) x-ray confirmed safe gastric placement.The tip of the tube "had come off" in the patients stomach.The patients bowel movements were monitored and the tip was recovered without incident.The was no reported injury or complication from the feeding tube.A medwatch, report number mw5078844, was received on (b)(6) 2018 stating, "rn placed 5 french ng in pt's right nare without difficulty.Rn unable to aspirate to ph confirmation.Rn then requested xray for placement confirmation.Upon review of xray, the tube was found coiled in the esophagus with the free tip broken off in the stomach.".
Additional Manufacturer Narrative
Correction: date of event (b)(4) 2018.Correction: expiration date 01-oct-2020.The device history record for the reported lot number, 202808069, in this complaint was reviewed and the material was produced according to the manufacturing procedures and met the quality requirements.One sample device was returned.During evelaution it was noted there was a separation/detachment of the bolus tip and tubing.The detached bolus tip was returned.There were signs of bonding agent on the tubing where the bolus tip and tubing was bonded together however, it was not visibly clear.The depth mark of the nasogastric (ng) tube to the y-port was measuring approximately 0.2cm.There was no damage noticed on the tube.The root cause of the reported issue could not be conclusively determined.All information reasonably known as of 03-oct-2018 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).

• Brand Name: CORFLO NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ANTI-IV CONNEC
• Common Device Name: DH CPK ANTI-IV (AIV) FEEDING TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 7811322
• Report Number: 9611594-2018-00133
• Device Sequence Number: 2076309
• Product Code: FPD
• UDI-Device Identifier: 10815149023752
• UDI-Public: 10815149023752
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K083210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2020
• Device Model Number: 20-9225AIV2
• Device Catalogue Number: 104577200
• Device Lot Number: 202808069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 08/23/2018
• Supplement Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1
• Patient Age: 3 DA