MAUDE Adverse Event Report: COVIDIEN EPUMP FEED AND 1000MLFLUSH SET; PUMP, INFUSION, ENTERAL

Model Number 773662

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2019

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

The customer reported the device presented a water leak in the union between the bag and the line.This occurred during priming.A patient was not involved therefore there was no patient injury, medical intervention, or adverse reaction associated with the event.

Manufacturer Narrative

The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and qa documentation.Five (5) used samples were received for evaluation.Visual inspection was performed, and no issue was detected.During functional evaluation leaking between the cross spike connector and the tubing line was detected.As part of continuous improvements, a corrective action has been opened to determine the root case and action plans.These actions will be designed to prevent the reoccurrence of the reported defective condition.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP FEED AND 1000MLFLUSH SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9402854
• MDR Text Key: 168862169
• Report Number: 1282497-2019-08800
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 30884521022106
• UDI-Public: 30884521022106
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

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: 773662
• Device Catalogue Number: 773662
• Device Lot Number: 191860086
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 11/21/2019
• Supplement Dates FDA Received: 03/19/2020
• Patient Sequence Number: 1