MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	762010E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Pain (1994); Foreign Body In Patient (2687); Pneumoperitoneum (4819)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion the results will be forwarded.
Event or Problem Description
The customer reported there was a piece that broke off and there was also additional rigidity to one of the pieces on the tube that seemed to be abnormal.Per additional information provided by the reporter, the product issues were discovered on (b)(6) 2025 when the patient went into the office for removal.Removal was attempted but was unsuccessful, requiring egd (esophagogastroduodenoscopy) procedure.Both the tube and internal bumper had additional rigidity.The internal bumper popped/broke off the tubing resulting in a foreign body that was noted during the egd for removal.Removal of the foreign body was performed on (b)(6) 2025 by (b)(6) via gastroscope.The patient experienced post procedure pain requiring an er visit and two-day hospital admission related to pneumoperitoneum.Medical treatment included pain control, iv antibiotics, and repeat scans to monitor pneumoperitoneum.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2400114564 was reviewed and no anomalies related to the reported issue were observed.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.One used device was provided for evaluation without the original packaging.The device had signs of possible manipulation including a non-standard tube length.As a result, we were unable to conduct thorough testing to confirm the reported issue or verify that the product was catalog number 762010e.As such, a root cause could not be determined at this time.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): CARDINAL HEALTH 200, LLC; 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: 21707509
• Report Number: 1423537-2025-00142
• Device Sequence Number: 21350145
• Product Code: KNT
• UDI-Device Identifier: 10192253009606
• UDI-Public: (01)10192253009606(17)250901(10)2400114564
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 09/01/2025
• Device Model Number: 762010E
• Device Catalogue Number: 762010E
• Device Lot Number: 2400114564
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown