MAUDE Adverse Event Report: AVANOS MEDICAL INC. CORFLO NAOGASTRIC/ NASOINTESTINAL FEEDING TUBES; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 40-8368

Device Problems Break (1069); Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/25/2022

Event Type  malfunction  

Event Description

Patient post op day 2 from heart transplant.Rn told by day shift rn that ng tube had some resistance but was able to flush, just slowly.At beginning at shift, rn able to flush w/sterile water with no issues.In morning, rn attempted to flush ng with sterile water to check it before administering tylenol.Rn flushed gently and noted sterile water come out of patient¿s nose.Rn stopped, pulled back on tube and removed approximately 61 cm of the tube and noted the end of it was broken/snapped.Rn alerted md, cxray and kub (chest x ray and kidney, ureter, bladder x-ray) ordered, team aware, rn unable to give tylenol.Per measurement, approx.29 cm left inside the pt.Per x-ray done earlier.Ng is weighted.The oropharynx was first carefully exposed using a tongue blade.Following this, the distal end of the keofeeding tube was visible.A pediatric magill forcep was then used to carefully grasp the feeding tube, and then used to remove the remaining distal end without any resistance.This was checked with the proximal segment (removed at time of rupture), and confirmed to be the full length of the feeding tube in entirety.There was an area of kinking in the tube just distal to site of rupture.Item sku: (b)(4).Corflo feeding tube ultra ped ng with stylet, 8 fr, 36" l.

• Brand Name: CORFLO NAOGASTRIC/ NASOINTESTINAL FEEDING TUBES
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 14336267
• MDR Text Key: 291208549
• Report Number: 14336267
• 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: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 40-8368
• Device Catalogue Number: 40-8368
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/28/2022
• Date Report to Manufacturer: 05/09/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 365 DA
• Patient Sex: Male