MAUDE Adverse Event Report: COVIDIEN LP KANGAROO; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884710859

Device Problem Break (1069)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 06/22/2022

Event Type  malfunction  

Event Description

Dobhoff nasogastric tube was placed without issue by md.After x-ray confirmed placement, md attempted to remove guide wire.Dobhoff was flushed as per protocol for guidewire removal and without significant pulling force the blue cap/ end tab broke off and guide wire punctured md's finger.Guidewire was immediately caught so not patient harm occurred.Additional staff were able to assist to safely remove the guidewire.Ng tube remained in place; no further intervention needed.

• Brand Name: KANGAROO
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP; 2101 faraday avenue; carlsbad CA 92008
• MDR Report Key: 14986637
• MDR Text Key: 295698252
• Report Number: 14986637
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 2112403464
• 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: 06/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 07/12/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31025 DA
• Patient Sex: Female
• Patient Weight: 69 KG
• Patient Race: White