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 08/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the tube was inserted on (b)(6) 2023 and a hole in the balloon was discovered on august 6, 2023.

Manufacturer Narrative

The device history record (dhr) review showed that manufacturing and inspection of product was performed as per applicable procedures and validated process.A sample analysis could not be performed because no samples were available for evaluation.The reported condition could not be confirmed.The affected component is produced by an external supplier.Due to similar cases presented in the past, a corrective and preventative action (capa) has been opened to further investigate this issue.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

The device history record (dhr) review showed that manufacturing and inspection of product was performed as per applicable procedures and validated processes.One decontaminated sample was received for evaluation.A visual inspection and a functional test were performed showing a leak in the inlet button through which sterile water is supplied to inflate the balloon.The reported issue was confirmed.The affected component is produced by an external supplier.Based on historical review, a corrective and preventative action (capa) was generated to the supplier to further investigate this issue.This complaint will be used for 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: 17556212
• MDR Text Key: 321239222
• Report Number: 9612030-2023-03801
• 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: 08/16/2023
• Supplement Dates Manufacturer Received: 08/10/2023; 08/10/2023
• Supplement Dates FDA Received: 09/15/2023; 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