MAUDE Adverse Event Report: COVIDIEN KANGAROO JOEY PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 10884521072305

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Rn was administering (b)(6) via ngt (salem sump) connected to a feeding tube extension.When pushing the aspirin, the increased pressure caused the feeding tubing to break close to where the tubing exits the joey pump.The feeding tube extension was not clamped, and the feeding tubing was connected to the extension set.Feeding bag/tube was retained with like packing information.Fda safety report id# (b)(4).

• Brand Name: KANGAROO JOEY PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 14416782
• MDR Text Key: 291981223
• Report Number: MW5109748
• Device Sequence Number: 1
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10884521072305
• Device Catalogue Number: 250228
• Device Lot Number: 220870307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Ethnicity: Hispanic
• Patient Race: White