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

Model Number 8884711253

Device Problems Difficult to Flush (1251); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/29/2022

Event Type  malfunction  

Event Description

Rn attempted to flush nasogastric (ng) feeding tube with 10 cc water to "reactivate" hydromer coating per manufacturer instructions.Feeding tube unable to flush after attempting both ports.Unable to remove guidewire after x ray confirmed placement of ng tube.As a result, ng tube was removed and replaced with a new one.Resulted in delay in care (tube feeding), additional procedure, and additional x ray.Device discarded by staff, no device to return.Tube not saved.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15111768
• MDR Text Key: 296700358
• Report Number: 15111768
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884711253
• Device Catalogue Number: 8884711253
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2022
• Date Report to Manufacturer: 07/27/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 21900 DA