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

Model Number 461055E

Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/14/2021

Event Type  malfunction  

Event Description

Elderly female - while attempting to remove ng tube for patient, the distal end became lodged in patients nasal passages.Rn informed md and charge rn, who also tried to assist without success.Rn obtained an order for ng tube removal via fluoroscopy.Under fluoroscopy, the ng tube was successfully moved.Patient arrived in xray for ng tube removal after multiple attempts on the floor.Viscous lidocaine was used to help numb the right nostril and with fluoro guidance they were able to remove the ng tube.Patient tolerated procedure well with no pain after the removal.The iris tube was removed with the lidocaine jelly and then fluoroscopy utilized to confirm the patient did not experience damage to her tissues.Manager states that according to the radiology practitioner the iris tube tips are larger than others making it more difficult to remove in some patients due to smaller size, sinus concerns.Of note the patient stated to bedside rn that she does have a deviated septum.There is no documentation of a deviated septum in the patient's record.*size and length of iris feeding tube is not documented and unknown.* manufacturer response for tubes, gastrointestinal (and accessories), kangaroo (per site reporter).There have been discussions about this concern with national representatives from cardinal health prior to this 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: 13391983
• MDR Text Key: 284704964
• Report Number: 13391983
• 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 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 Age: 29200 DA
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White