MAUDE Adverse Event Report: COVIDIEN EPUMP 1000ML PUMP SET; PUMP, INFUSION, ENTERAL

Model Number 773656

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 04/22/2019

Event Type  malfunction  

Manufacturer Narrative

Initial reporter information is unknown at this time.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 reports the tubing from the feeding bag disconnected and milk started leaking.There was no harm to the patient.

Manufacturer Narrative

Additional information: e1: added facility name, address, and email contact information.

• Brand Name: EPUMP 1000ML PUMP SET
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 8708709
• MDR Text Key: 148324440
• Report Number: 1282497-2019-08505
• Device Sequence Number: 1
• Product Code: LZH
• UDI-Device Identifier: 10884521022096
• UDI-Public: 10884521022096
• 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: 07/08/2019

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: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 83040088
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/04/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 06/04/2019
• Supplement Dates FDA Received: 07/08/2019
• Patient Sequence Number: 1