MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 712120

Device Problem Unintended Deflation (4061)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the balloon was filled with water once installed to test integrity and water was coming out from a pin hole.

Manufacturer Narrative

Additional information was received from the the initial reporter therefore section b5 was updated to add more details.H6 component code was also added.

Event Description

The customer reported that the balloon was filled with water once installed to test integrity and water was coming out from a pin hole.Additional information received on (b)(6)2023 stated that the pin hole was at the end of the balloon, and appeared soon after insertion- within a week or 2.

Manufacturer Narrative

Based on the information available to us, we were unable to confirm the event.However, a supplier corrective action request was opened to further investigate the issue.In the meantime, all information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 12 FR X 1.2 CM
• 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: jilil saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17818191
• MDR Text Key: 324267168
• Report Number: 9612030-2023-03833
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 11/06/2023

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: 712120
• Device Catalogue Number: 712120
• Device Lot Number: 2020328864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/26/2023
• Supplement Dates Manufacturer Received: 09/13/2023; 09/13/2023
• Supplement Dates FDA Received: 09/29/2023; 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2020
• Type of Device Usage: A
• Patient Sequence Number: 1