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

Model Number	461438E
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One physical sample and two photos were received for investigation.The sample and photos were visually inspected, and the reported condition was confirmed.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Based on all available information, 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.
Event or Problem Description
The customer reported that the tube was cut at the 7 marks on the tube.According to the staff they have seen this before where the tube has been cut but it was much more obvious previously.They were thinking that because of the length of the tube it sometimes gets caught when heat sealing the packaging.This tube was inside of a patient in the nicu, and the reported issue was noticed on removal.There was no patient harm reported.

• 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: 20422692
• Report Number: 1423537-2024-00215
• Device Sequence Number: 15575242
• Product Code: PIF
• UDI-Device Identifier: 10884521547148
• UDI-Public: (01)10884521547148(17)281231(10)2400208464
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• 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: 461438E
• Device Catalogue Number: 461438E
• Device Lot Number: 2400208464
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown