MAUDE Adverse Event Report: CARDINAL HEALTH, INC. KANGAROO ENTERAL FEEDING SET WITH 1000ML FLUSH BAG; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problem Leak/Splash (1354)

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

Event Date 04/29/2019

Event Type  malfunction  

Event Description

During an enteral feeding line assessment the clinician noted leaking from the bottom section of the spike introducer connection.The clinician noted that this leaking issue has been occurring on several sets.The feeding set was discontinued from the patient and sent to biomedical engineering for review and reporting.Biomedical found from follow up that the enteral twist spike assembly inserts in the feeding solution bag and twists into place normally.Once tubing is primed past the bifurcated level valve the clinician will notice leaking right at the bottom of the twist spike assemble where the tubing is fused to the spike.The threaded locking collar still rotates and locks into the feeding reservoir or bag.

• Brand Name: KANGAROO ENTERAL FEEDING SET WITH 1000ML FLUSH BAG
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8611427
• MDR Text Key: 145091556
• Report Number: 8611427
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• 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: 05/01/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1