MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 24 FR X 1.7 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 724170

Device Problem Unintended Deflation (4061)

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

Event Date 01/29/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported on (b)(6) 2022 at 6:00 am, the skin level balloon gastrostomy tube was placed in the patient.The device functioned normally until 9:00 pm on (b)(6) 2022, where a local leak was detected by the patient's caregiver causing the total rupture of the probe (balloon).On (b)(6) 2022, a provisional probe was placed.There was no harm to the patient.

Manufacturer Narrative

H4 manufacture date added investigation summary the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections, per established sampling levels were within acceptable limits during the production process a video was provided.In the video it can be seen that the balloon is leaking; however, an analysis of what could have caused this issue cannot be done without the sample to evaluate.The reported condition could not be confirmed as related to the manufacturing process.The complaint will be reopened if a sample is received.All associated lot documentation was carefully reviewed.No issues or discrepancies were found related to the reported complaint.No non-conformities nor deviations related to a hole in the balloon tube were reported for this lot.No action plan could be performed.Current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing site will continue to monitor the process, customer complaints, and feedback notifications for any adverse trends that require immediate attention.In case of repeated issues and/or recurrence, a new investigation for the specific events would be carried out for each case.This complaint will be used for tracking and trending purposes.

Manufacturer Narrative

Device evaluation: the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections, per established sampling levels were within acceptable limits during the production process a video and a sample were received at the manufacturing site for evaluation.A visual inspection and a functional test were performed showing a leak in the tube part of the balloon due to a small perforation.The reported condition was confirmed.A corrective and preventative action (capa) was generated to the supplier of the product for further investigation of the issue.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 24 FR X 1.7 CM
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraia ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13659679
• MDR Text Key: 286508345
• Report Number: 9612030-2022-03185
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521011403
• UDI-Public: 10884521011403
• 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,Followup
• Report Date: 07/20/2022

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 Expiration Date: 12/31/2023
• Device Model Number: 724170
• Device Catalogue Number: 724170
• Device Lot Number: 1833704964
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/03/2022
• Supplement Dates Manufacturer Received: 02/21/2022; 02/21/2022
• Supplement Dates FDA Received: 04/11/2022; 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2018
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 52 KG