MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	714170
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the tube was inserted on (b)(6) 2022 and a broken shaft resulted in leakage presented to the emergency department on (b)(6) 2022.No injury reported.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.However a corrective and preventive action was opened to further investigate the reported issue.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 14 FR X 1.7 CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17450489
• Report Number: 9612030-2023-03778
• Device Sequence Number: 7366627
• Product Code: KNT
• UDI-Device Identifier: 10884521010659
• UDI-Public: 10884521010659
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup
• Report Date (Section B): 08/21/2023

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: 714170
• Device Catalogue Number: 714170
• Device Lot Number: 2115322364
• 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: 07/24/2023
• Supplement Date Received by Manufacturer: 07/24/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/21/2023
• Date Device Manufactured: 06/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown