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

Model Number 716170

Device Problem Unintended Deflation (4061)

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

Event Date 01/23/2024

Event Type  malfunction  

Event Description

The customer reported that the balloon was placed on the patient on (b)(6) 2023 and on (b)(6) 2024, the balloon burst.There was no harm reported.

Manufacturer Narrative

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

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The product was manufactured on 11-aug-2021.Four pictures were provided for evaluation.Upon reviewing the pictures, the reported condition was confirmed; however, through the pictures it is not possible to determine the root cause of the reported issue.The affected component is produced by an external supplier.A supplier corrective and preventive action has been initiated to address the reported issue.

• Brand Name: BALLOON SLG 16FR X 1.7CM
• 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: 18615875
• MDR Text Key: 334510776
• Report Number: 9612030-2024-00033
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 2121525764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1