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 11/25/2019

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 is leaking below the spike cap where the tubing connects.

Manufacturer Narrative

The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two samples were received at the manufacturing site for evaluation.Visual and functional evaluations were performed, and the reported condition was confirmed, the feeding sets were leaking.As part of continuous improvements, a corrective action has been opened to address the reported issue.This action is designed to prevent the recurrence of the reported and confirmed condition.The root cause and action plan will be documented through the formal investigation.This complaint will be used for qa 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 02048
• MDR Report Key: 9398185
• MDR Text Key: 169247866
• Report Number: 1282497-2019-08791
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

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: 775100
• Device Catalogue Number: 775100
• Device Lot Number: 192450101
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/02/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 03/11/2020
• Patient Sequence Number: 1