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 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that the tubing leaked near the spike connector during set up.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.A sample was not returned to the manufacturing site for evaluation however a photograph was submitted with the complaint report.An examination of the photograph demonstrates that a leak was detected near the cross spike the root cause and corrective/preventative actions (capa) for the reported condition is confirmed to be related to a manufacturing/production process.A formal capa has been issued and is currently in process.This complaint will be closed with no further action.If sample is received later, the complaint will be reopened for investigation.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 02048
• MDR Report Key: 9527418
• MDR Text Key: 173035397
• Report Number: 1282497-2019-08843
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 03/30/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 03/30/2020
• Patient Sequence Number: 1