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

Model Number 40-9438

Device Problems Break (1069); Complete Blockage (1094)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

User facility submitted medwatch #0533050000-2021-8042 is attached for reference.A review of the device history record is not possible as no lot number was provided.The sample is reported to be available, but has not yet been received by the manufacturer.Photos of the device were provided by the user facility.All information reasonably known as of (b)(6) 2021 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).Device not returned.

Event Description

It was reported that the ng [nasogastric] tube was broken.The bedside nurse described difficulty in administering around the clock tylenol for the patient.An x-ray was taken to confirm tube placement and the dissected tube was found inadvertently.Nightshift nursing staff and the mother of the patient reported that medication administration had been an "intermittent ongoing issue" where medications would backflow if administered in the opposite port.At one point half the dose of tylenol was able to be given before heavy resistance was met.An attempt to unclog the tube was made with sterile water and a smaller syringe, but this attempt was met with resistance and backflow.Clog zapper was ultimately used and both ports had no issue following use.The last 30cm of tubing was reported to be discolored and dark brown.The patient was nasally intubated with mouth wired shut.The patient had to be scoped at bedside to remove the broken tube.Additional information received 26-mar-2021 indicated the ng tube was placed on (b)(6) 2021 and found to be broken on x-ray on (b)(6) 2021.The tube was used to administer "feeds and liquid medications (ibuprofen, tylenol, decadron) and miralax." an "esophagogastroduodenoscopy with removal of foreign body" was required and all parts of the tube were removed.Patient "recovered and was discarded on (b)(6) 2021." additional information was received on 29-mar-2021 from medwatch/fda user facility report #mw0533050000-2021-8042.Complaint description: "infant admitted for plastics reconstruction s/p dog bite injury.On routine cxr (chest x-ray) today, 8 fr post-pyloric feeding tube was found to be broken in 2 places inside patient.Patient intubated, jaw previously wired shut, had been in or few days earlier.Lips remained sutured closed on one side.Patient had been receiving continuous post-pyloric feeds.Radiologist read on cxr 'interval discontinuity of the jejunal feeding tube at the level of the gastric fundus.' mds [physicians] notified, feeds were held.Plastics came to bedside, patient was scoped and both portions of feeding tube were retrieved.Both ends of the tube (at broken site) appeared to have burst.Investigation to manufacturer regarding feeding tube as i saw a similar feeding tube a while back.Per staff, it was also an 8 fr tube.The last 30cm of tubing (which included part broken) was very discolored - dark brown.This event had minimal temporary harm to the patient." additional information has been requested but not yet received.

Manufacturer Narrative

The product involved in the report has been returned.The investigation remains in progress.All information reasonably known as of 27 apr 2021 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.

Manufacturer Narrative

The returned device was examined under magnification and the tube showed signs of damage.A split/tear was identified approximately at the 20cm marking.The tubing appeared to have expanded to form a balloon shape which burst axially causing separation of the tubing into two pieces.The tube was able to be flushed from the y-port; however, the distal end portion of the tube was unable to be flushed.This portion of the tube appeared to be clogged as resistance was met during flushing.The distal end exhibited dried build-up in the inner surface.Discoloration was noticed on the exterior of the tubing starting from the 35 cm mark until the end tip of the tube.A root cause could not be conclusively determined.However, this seems to be a use related problem since as per the ifu, vigorous syringe force should not be used to irrigate, administer liquids, or unblock the tube.All information reasonably known as of 24 may 2021 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 FEEDING TUBE WITH STYLET WITH ENFIT CONNECT
• Type of Device: DH CPK NG TUBES
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11633928
• MDR Text Key: 258980574
• Report Number: 9611594-2021-00052
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 00035077046050
• UDI-Public: 0035077046050
• Combination Product (y/n): N
• PMA/PMN Number: K821906
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 40-9438
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/17/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 04/12/2021; 05/10/2021
• Supplement Dates FDA Received: 04/27/2021; 05/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DECADRON.; IBUPROFEN.; MIRALAX.; TYLENOL.
• Patient Outcome(s): Required Intervention
• Patient Age: 23 MO
• Patient Weight: 14