MAUDE Adverse Event Report: COVIDIEN LP KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710859
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported they couldn't remove the guide wire once inserted.Per additional information provided on january 22, 2026, the hydromer coating on the inner diameter of the tube was not activated by injecting approximately 10 ml of water prior to insertion as staff were not aware of this requirement prior to insertion.They attempted to flush with 10ml of water after placing the tube but the stylet would not loosen.The tube was removed and replaced with a salem sump ng as the weighted tubes would not release the guidewire even with the activation of the hydromer coating.There was no significant harm to the patient, just the discomfort of additional ng insertion and manipulation of the initially inserted tube.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported they couldn't remove the guide wire once inserted.
Additional Manufacturer Narrative
One used device was received for investigation.The device was evaluated but the reported condition was not observed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.During production, inspectors routinely examine a statistical sample both physically and visually.A gemba walk was held in the production area.As a result, it was concluded that the current manufacturing activities are running according to product specifications meeting quality acceptance criteria, validation processes, and released procedures.The investigation was carried out with the multifunctional team, all processes and controls were found to be followed correctly, including packaging and all inspections performed on the product.No conditions were found that could trigger the reported condition.Based on all available information, a definitive root cause could not be determined at this time.The potential root cause indicates that this problem could occur due to improper use of the procedure if the instructions for use are not followed.We will continue to monitor related reports to determine if additional actions are necessary.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 24067625
• Report Number: 1423537-2026-00011
• Device Sequence Number: 18420380
• Product Code: KNT
• UDI-Device Identifier: 10884521518766
• UDI-Public: (01)10884521518766(10)2219308964
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 2219308964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 01/22/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown