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

Model Number	724200
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
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.The device was manufactured on october 15, 2019.A sample was not received for the investigation.Without a sample we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue.The reported affected component is produced by an external supplier and our assembly process consists only of a pick and place operation for this material.A supplier corrective action request has been sent to the supplier to further investigate the reported condition.This complaint will be used for tracking and trending purposes.
Event or Problem Description
The customer reported the device was placed on june 22, 2023 and externalization occurred due to a micro-hole in the cuff on july 12, 2023.

• Brand Name: KANGAROO
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: 20524301
• Report Number: 1423537-2024-00267
• Device Sequence Number: 9171484
• Product Code: KNT
• UDI-Device Identifier: 10884521011410
• UDI-Public: (01)10884521011410(17)240930(10)1928304064
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K954429
• 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
• Report Date (Section B): 10/24/2024

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 Expiration Date: 09/30/2024
• Device Model Number: 724200
• Device Catalogue Number: 724200
• Device Lot Number: 1928304064
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/24/2024
• Date Device Manufactured: 10/15/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown