MAUDE Adverse Event Report: COVIDIEN 974655R KANGAROO EPUMP SET X30; PUMP, INFUSION, ENTERAL

Model Number 974655R

Device Problem Fluid/Blood Leak (1250)

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

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

Customer reports: thirty minutes after feeding started, the formula leaked from the attachment part between the catheter's female connector and the tube.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two decontaminated sample were received at the manufacturing site for evaluation.Upon a visual evaluation under micro zoom, the reported issue was confirmed; there was missing glue loctite 4011 at the bonding point.A root cause analysis indicated that this issue has occurred as a result of the manufacturing process.The glue needle used during the assembly process did not supply a sufficient amount of glue to cover the tubing.As part of continuous improvements, the following actions have been taken.Training has been provided to operators, 100% visual inspections have been implemented, and the glue needle has been improved to increase the area at the end of the needle to allow easier rotation of the tube by the operator during assembly.These actions are designed to prevent the recurrence of the reported and confirmed condition.This complaint will be used for tracking and trending purposes.

• Brand Name: 974655R KANGAROO EPUMP SET X30
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 117 moo 2, petchkasem rd, samp; nakorn pathom 73110 ; TH 73110
• MDR Report Key: 10233516
• MDR Text Key: 198358777
• Report Number: 8040459-2020-00533
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 974655R
• Device Catalogue Number: 974655R
• Device Lot Number: 1824343FEP
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/03/2020
• Patient Sequence Number: 1