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 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine a root cause.A supplier corrective action request was forwarded to the supplier to further investigate the reported issue.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

Event Description

The customer reported that the balloon was filled with water once installed to test integrity and water was coming out from a pin hole.Additional information received on (b)(6) 2023 stated that the pin hole was at the end of the balloon, and appeared soon after insertion- within a week or 2.

• 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: 17851745
• MDR Text Key: 324693811
• Report Number: 9612030-2023-03835
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 10/02/2023

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: 712120
• Device Catalogue Number: 712120
• Device Lot Number: 2103419064
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/02/2023
• Date Device Manufactured: 02/18/2021
• Type of Device Usage: A
• Patient Sequence Number: 1