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 Consequences Or Impact To Patient (2199)

Event Date 02/21/2020

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.

Event Description

The customer reported that the tubing of the feeding set spontaneously ripped during infusion of formula with senna, a stool softener.The bag was infusing with no issues prior.There was no patient injury.Additional information was received on 26-mar-2020 stating that there was a partial detachment on the tubing where the hard plastic meets the stretchy part which caused leaking.

Manufacturer Narrative

A device history record could not be reviewed because a lot number could not be provided by the customer.One used sample was received for evaluation.A visual and functional inspection was completed and confirmed the reported issue; the tubing was detached.The root cause may be related to a manufacturing/production process.As there are no trends for the reported issue, a formal corrective action will not be initiated at this time.We will continue to trend this issue for future occurrences as part of the complaint review process.

• 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: 9916114
• MDR Text Key: 186212977
• Report Number: 1282497-2020-08993
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2020
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/24/2020
• Patient Sequence Number: 1