MAUDE Adverse Event Report: CARDINAL HEALTH BALLOON SLG 12 FR X 1.2 CM; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 712120

Device Problem Unintended Deflation (4061)

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

Event Date 05/13/2022

Event Type  malfunction  

Event Description

The customer reported that the gastrostomy feeding tube was removed due to a "hole" in the balloon.A test was performed and the leak was identified.The procedure was performed on (b)(6) 2022 and the material was removed on (b)(6) 2022.

Manufacturer Narrative

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

Manufacturer Narrative

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.No sample was returned for evaluation.Three (3) photos were provided, and one shows the leak in the balloon.The complaint will be reopened if a sample is received.The reported condition is confirmed through the photo.This product is manufactured by a supplier.The root cause of this issue will be determined by the supplier and documented under a supplier corrective action report.This complaint will be used for tracking and trending purposes.

• Brand Name: BALLOON SLG 12 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: 15031909
• MDR Text Key: 302843609
• Report Number: 9612030-2022-03324
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521010499
• UDI-Public: 10884521010499
• 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: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 712120
• Device Catalogue Number: 712120
• Device Lot Number: 1916226264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2022
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1