MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 16FR X 3.5CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 716350

Device Problem Deflation Problem (1149)

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

Event Date 12/28/2022

Event Type  malfunction  

Event Description

The customer reported that the tube was inserted on (b)(6) 2022 and the balloon burst on (b)(6) 2022.There was no harm reported.Additional information was received and stated that the hole causing balloon to deflate and size of hole not specified.It was a clean tear.There was a no patient 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 device was manufactured on 22-feb-2021.A sample have not yet been received at the manufacturing site for investigation.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Since the device is provided by an external supplier, a corrective action (capa) has been generated to the supplier to determine the root cause and corrective and preventive actions, if required.This complaint will be used for tracing and trending purposes.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on (b)(6), 2021.One physical sample was received at the manufacturing site for investigation.The sample was visually and functionally inspected, and the reported condition was confirmed.The affected component is produced by an external supplier.A supplier corrective action request (scar) has been issued to the supplier for further investigation and to address the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 16FR X 3.5CM
• 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: 16132374
• MDR Text Key: 308585256
• Report Number: 9612030-2023-03517
• 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: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 716350
• Device Catalogue Number: 716350
• Device Lot Number: 2104813764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1