MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number	461420E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that covidien kangaroo polyurethane feeding tubes (6.5fr) ref 461420e, had manufacture error.Per customer, it looks like during production, the tubes were cut off while sealing the packages.
Additional Manufacturer Narrative
A physical sample was not received for investigation, but a photo was provided.The photo was reviewed, and the reported condition was confirmed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A definitive root cause could not be determined at this time.However, actions have been implemented to address the reported condition.All information received will be used for further tracking and trending purposes.

• Brand Name: KANGAROO
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 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: 20407202
• Report Number: 1423537-2024-00209
• Device Sequence Number: 3378886
• Product Code: PIF
• UDI-Device Identifier: 10884521547131
• UDI-Public: (01)10884521547131(17)280531(10)2316418364
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K150084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2024

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: 461420E
• Device Catalogue Number: 461420E
• Device Lot Number: 2316418364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown