MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY ENPLUS SPIKE WITH FLUSH BAG; PUMP, INFUSION, ENTERAL

Catalog Number 765100

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

The spike of the joey tube feeding flush bag was leaking after spiking tube feed.Fda safety report id# (b)(4).

• Brand Name: KANGAROO JOEY ENPLUS SPIKE WITH FLUSH BAG
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN ; mansfield MA 02048
• MDR Report Key: 12180452
• MDR Text Key: 262190929
• Report Number: MW5102569
• Device Sequence Number: 1
• Product Code: LZH
• 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: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 765100
• Device Lot Number: 211020120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Weight: 103