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 Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

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 that the device presented with a water leak when the water infusion was started.

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.One sample was received for evaluation.Visual and functional inspection was performed, and a cut was found on the bottom of the bag.A root cause related to the manufacturing/production process could not be determined.The most probable root cause could be related to incorrect use of the product.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 st; mansfield MA 02048
• MDR Report Key: 9445271
• MDR Text Key: 170096796
• Report Number: 1282497-2019-08816
• 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: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• 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: 191890075
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2019
• Patient Sequence Number: 1