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

Model Number 773656

Device Problems Bent (1059); Kinked (1339); No Flow (2991)

Patient Problem Feeding Problem (1850)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/11/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an enteral feeding pump set.The customer reports that where the tube and bag connect there are kinks, dents and bends; due to this, the formula will not feed.

Manufacturer Narrative

Samples were not received for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If the sample is received, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EPUMP 1000ML PUMP SET
• Type of Device: ENTERAL FEEDING PUMP SET
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6018260
• MDR Text Key: 57399533
• Report Number: 1282497-2016-00794
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 773656
• Device Catalogue Number: 773656
• Device Lot Number: 161970193
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1