MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 1.7CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	716170
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Failure to Anastomose (1028); Pain (1994)
Date of Event	03/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reports: the shaft of the skin level device (sld) was broken, just prior to the time that it was due for a regular change.The patient went to the emergency department in pain with a leaking stoma for a day.The sld was found to be leaking.The patient was referred to the percutaneous endoscopic gastrostomy (peg) clinic in 4 days time with skin burns around the sld dressings.
Additional Manufacturer Narrative
Based on the information available to us, we were unable to confirm the event.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 16FR X 1.7CM
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02748
• 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: 17970215
• Report Number: 9612030-2023-03840
• Device Sequence Number: 7670553
• Product Code: KNT
• UDI-Device Identifier: 10884521010994
• UDI-Public: 10884521010994
• 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): 01/26/2024

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: 716170
• Device Catalogue Number: 716170
• Device Lot Number: 2113126564
• 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: 10/17/2023
• Supplement Date Received by Manufacturer: 10/17/2023
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/26/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown