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	06/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A physical sample was not received for investigation, but a photo provided.The image was reviewed, and it was not possible to confirm the reported condition or determine the root cause based on the photo alone.However, actions have been implemented to address the reported condition.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.All information received will be used for further tracking and trending purposes.
Event or Problem Description
The customer reported that when package was opened for the placement in a patient, it was found to be cut in half.The product was not used on the patient.Per customer, the flush was connected to female piece and when attached to male, it leaked where flush connects to female.The customer got another one and it worked.Additional information was received from the customer and stated that the tube was partially cut (severed) through inside the sterile packaging.The packaging was not damaged or broken prior to the nurse using it.The registered nurse (rn) flushed the connector and it leaked out of the cut.The tube was not used on a patient.

• 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: 20410265
• Report Number: 1423537-2024-00210
• Device Sequence Number: 18418212
• Product Code: PIF
• UDI-Device Identifier: 10884521547131
• UDI-Public: (01)10884521547131(17)281130(10)2334206064
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 461420E
• Device Catalogue Number: 461420E
• Device Lot Number: 2334206064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 10/09/2024
• Date Device Manufactured: 12/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown