MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12FR X 1.0CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 712100

Device Problem Break (1069)

Patient Problems Irritability (2421); Swelling/ Edema (4577)

Event Date 07/22/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported that the tube was inserted on (b)(6) 2023 and a broken shaft was discovered on (b)(6) 2023.Presented to ed with swollen site and irritable child.

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.A sample was not received for the investigation and the device history record was reviewed and indicated that the product was released accomplishing all quality standards.However, a corrective and preventive action has been initiated to address the reported issue.In the meantime, all information received will be used for further tracking and trending purposes.

Manufacturer Narrative

Based on the information available to us, we were able to confirm the event, and determined through visual and functional testing of the returned device that it was broken at the union between the valve and tube of the balloon which caused a leak.A corrective and preventive action was initiated to further investigate this issue.All information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 12FR X 1.0CM
• Type of Device: 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: 17628084
• MDR Text Key: 322038505
• Report Number: 9612030-2023-03812
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 712100
• Device Catalogue Number: 712100
• Device Lot Number: 2210209964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1