MAUDE Adverse Event Report: COVIDIEN COVIDIEN; KEOFEED TUBE

Catalog Number 8884-721252

Device Problem Dislocated (1178)

Patient Problem Pneumothorax (2012)

Event Date 06/03/2015

Event Type  Injury  

Event Description

Three patients ( 4 events) of pneumothorax requiring chest tube placement with insertion of keofeed tubes.Covidien kangaroo nasogastric feeding tube 12fr weighted tip, rigid port, stylet; ref # 8884 - 721252; lot # 508381164x.

• Brand Name: COVIDIEN
• Type of Device: KEOFEED TUBE
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 4871988
• MDR Text Key: 6046028
• Report Number: 4871988
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8884-721252
• Device Lot Number: 508381164X
• Other Device ID Number: 8884-721252
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2015
• Distributor Facility Aware Date: 06/15/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other