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

Model Number	716170
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the tube was inserted on (b)(6) 2023 and the balloon burst 2 days later on (b)(6) 2023.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date was added the device history record (dhr) was reviewed showing no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.Sample evaluation could not be performed because no sample nor photo was available for evaluation.Due to previous similar complaints, a corrective and preventive action (capa) had been opened to further investigate the issue.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
The device history record (dhr) review showed that manufacturing and inspection of product was performed as per applicable procedures and validated processes.One decontaminated sample was received for evaluation.A visual inspection and a functional test were performed showing a leak at the tip part of the tube.The reported issue was confirmed.The affected component is produced by an external supplier.Based on historical review, a corrective and preventative action (capa) was generated to the supplier to further investigate this issue.This complaint will be used for 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 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: 17181704
• Report Number: 9612030-2023-03732
• Device Sequence Number: 17807172
• 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,Followup
• Report Date (Section B): 03/26/2024

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: 2223526364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 06/21/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 08/03/2023; 03/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown