MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML SAFETY SCREW SPIK; PUMP, INFUSION, ENTERAL

Model Number 775100

Device Problem Leak/Splash (1354)

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

Event Date 12/17/2019

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 had a leak at the connection between the nutrition and the set.

Manufacturer Narrative

The lot number was provided and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used sample was received for the evaluation.Upon visual and functional inspection, the reported condition could not be confirmed because the sample is inadequate, had food in the cross spike and there were molds in the sample returned.No formal investigation action is being taken since the issue could not be confirmed related to manufacturing/production process.This complaint will be used for tracking and trending purposes.

• Brand Name: EPUMP 1000ML SAFETY SCREW SPIK
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA
• MDR Report Key: 9545624
• MDR Text Key: 173578325
• Report Number: 1282497-2020-08851
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521155817
• UDI-Public: 10884521155817
• 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: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 192310131
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/30/2019
• Patient Sequence Number: 1