MAUDE Adverse Event Report: COVIDIEN / CARDINAL HEALTH 200, LLC. ARGYLE FEEDING TUBE, 5 FRENCH; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Catalog Number 460802E

Patient Problem Foreign Body In Patient (2687)

Event Date 12/07/2023

Event Type  Injury  

Event Description

During partial cystectomy, the paper label attached to tubing dislodged and was unintentionally retained in the bladder.

• Brand Name: ARGYLE FEEDING TUBE, 5 FRENCH
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN / CARDINAL HEALTH 200, LLC.
• MDR Report Key: 18606608
• MDR Text Key: 334200083
• Report Number: MW5150872
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 460802E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Male