MAUDE Adverse Event Report: COVIDIEN KANGAROO ENPLUS SPIKE ; PUMP, INFUSION, ENTERAL

Model Number REF 775100

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/04/2019

Event Type  malfunction  

Event Description

Tube feeding spike with flush bag was leaking.Tube feeding was spiked with purple spike and the tube began leaking.This occurred a total of 7 instances with 3 different nurses.Fda safety report id# (b)(4).

• Brand Name: KANGAROO ENPLUS SPIKE
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN ; mansfield MA 02048
• MDR Report Key: 8981344
• MDR Text Key: 158640669
• Report Number: MW5089645
• Device Sequence Number: 6
• Product Code: LZH
• 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: 09/05/2019
• 7 Devices were Involved in the Event: 1 2 3 4 5 6 7

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: REF 775100
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/09/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 77