MAUDE Adverse Event Report: COOK INCORPORATED CAREY ALZATE COONS; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number G02956

Device Problems Disconnection (1171); Device Inoperable (1663)

Patient Problem No Code Available (3191)

Event Date 05/11/2017

Event Type  malfunction  

Event Description

Patient transferred from facility for gj tube replacement.The red cap was found disconnected off of the tube causing the gj tube unusable and required replacement.

• Brand Name: CAREY ALZATE COONS
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COOK INCORPORATED; 6300 n. matthews dr.; ellettsville IN 47429
• MDR Report Key: 6666774
• MDR Text Key: 78386658
• Report Number: 6666774
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: G02956
• Device Catalogue Number: GJS-1020
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2017
• Event Location: Other
• Date Report to Manufacturer: 06/21/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR