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

Model Number	714170
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that after the test, the button 14fr 1.5cm was installed, but after 3 days of use, the balloon ruptured, making it impossible to use.No injury was reported.
Additional Manufacturer Narrative
Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A corrective and preventive action was opened with the supplier to further investigate the reported issue.The complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Based on an update received by the initial reporter on (b)(6) 2023 the following sections were corrected with updated information: b5 describe event or problem; d1 brand name; d4 model number, catalog number, udi #.
Event or Problem Description
The customer reported that after the test, the button 14fr 1.7cm was installed, but after 5 days of use, the balloon ruptured, making it impossible to use.No injury was reported.
Additional Manufacturer Narrative
One device was returned for evaluation.When water was injected into the returned device, a leak was detected due to a broken balloon.A supplier corrective action report was opened to further investigation this issue.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: 17192304
• Report Number: 9612030-2023-03739
• Device Sequence Number: 5869536
• Product Code: KNT
• UDI-Device Identifier: 10884521010659
• UDI-Public: 10884521010659
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup,Followup
• Report Date (Section B): 12/21/2023

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: 1931614364
• 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: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023; 06/22/2023; 06/22/2023
• Initial Report FDA Received Date: 06/23/2023
• Supplement Report FDA Received Date: 06/27/2023; 08/08/2023; 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2019
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown