MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 461055E

Device Problems Entrapment of Device (1212); Difficult to Insert (1316); Difficult to Remove (1528); Failure to Advance (2524); Malposition of Device (2616); Patient Device Interaction Problem (4001); Physical Resistance/Sticking (4012)

Patient Problems Failure of Implant (1924); Inflammation (1932); Low Oxygen Saturation (2477); Device Embedded In Tissue or Plaque (3165); Swelling/ Edema (4577)

Event Date 08/30/2021

Event Type  malfunction  

Event Description

Elderly male admitted for covid-19 pneumonia and extended intubation time.Feeding tube with iris technology inserted at 1900.Removal was around 2300 on same day."this rn went to insert an ngt using iris technology.Pt was found pleasant and amenable to procedure.Insertion was difficult and tube was only able to be advanced to 47 cm.At 47 cm, tube met significant resistance was was not able to be advanced further.At this point, pt was desaturating significantly and not tolerating well.Ng was unable to be bridled as both nares were significantly swollen.Pt asked this rn to "stop please." ng taped to cheek, x ray to follow.This procedure took approx.45 minutes." radiology report at 2128: "enteric tube extends into the right main bronchus.Malpositioned enteric tube terminates in the right main bronchus.These findings were discussed with the patient's nurse." "2300: pt had ng placed at 1900.Xray for placement showed that ng was not in correct position, see radiology notes.Attempted to pull iris ng tube with charge nurse in the room, was able to pull it until around 10 cm left and ng camera tip got lodged in nasal cavity due to inflammation.Critical care rn came to room with the iris console and was able to advance the tip of the ng tube back into the patients mouth to where then the tubing was cut and removed.Patient tolerated well.Md notified." "iris camera lodged in nasal passage due to inflammation.Critical care nurse came to bedside, advanced tubing until we could see the camera tip in the mouth, able to clip the tubing and able to pull tube out from left nare and mouth.Patient tolerated well." *exact size and length of iris tube is not documented.Unable to determine lot/serial # due to packaging discarded.* ¿difficulty placing iris nasogastric tube but was completed at 1900.The chest xray revealed that the tube was in the right bronchus.The rn attempted to pull the ng tube but it did not pull easily and was stuck at the 10 cm line.The rapid response nurse was called for assistance and the iris representative was called.The rep stated that this has occurred before after difficult placements.He suggested that the tissue was swollen and the camera on the end could not fit through the constricted nasal passage.He suggested to hook the tube back up to the camera and push it back enough to be able to visualize it in the mouth and then pull it through that way.A neuro critical care nurse who has greater experience with iris was called and the tube was removed by pulling it through the oral cavity and cutting off the camera portion and then pulling the rest out through the nare.Reinsertion did not occur at the patient's son's request and the physician was made aware.¿ manufacturer response for tubes, gastrointestinal (and accessories), kangaroo (per site reporter) there was a conversation with national cardinal health representatives prior to this event report.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 13391980
• MDR Text Key: 284704859
• Report Number: 13391980
• 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: 11/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/11/2021
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24820 DA
• Patient Sex: Male
• Patient Weight: 78 KG