MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 14 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 714120

Device Problem Unintended Deflation (4061)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

The customer reported that the tube was inserted on (b)(6) 2023 and a pinhole in tip of balloon was discovered on (b)(6) 2023.

Manufacturer Narrative

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

Manufacturer Narrative

We have concluded our investigation process related to the reported complaint.Based on the information available to us, we were unable to confirm the event.However, a supplier corrective action report has been opened to further investigate this 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 unable to confirm the event.The device was returned and evaluated; no leaking or device problems were found.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Although the reported issue was not confirmed, a corrective and preventive action was initiated to further investigate the reported issue.All information received will be used for further tracking and trending purposes.

• Brand Name: BALLOON SLG 14 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: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 17627825
• MDR Text Key: 322033823
• Report Number: 9612030-2023-03814
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 714120
• Device Catalogue Number: 714120
• Device Lot Number: 2211009964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2023
• Initial Date FDA Received: 08/25/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 08/10/2023
• Supplement Dates FDA Received: 10/12/2023; 03/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1