MAUDE Adverse Event Report: COVIDIEN EPUMP INTL 1000ML FD AND FLUSH; ENTERAL FEEDING BAG

Model Number 673662

Device Problem Obstruction of Flow (2423)

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

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that an issue occurred with an enteral feeding bag.The customer reports when the enteral nutrition is installed, the double bag equipment is obstructed.

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the complaint 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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: EPUMP INTL 1000ML FD AND FLUSH
• Type of Device: ENTERAL FEEDING BAG
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana ; MX
• Manufacturer (Section G): NELLCOR; 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: 6218690
• MDR Text Key: 64026907
• Report Number: 1282497-2017-00004
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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: 673662
• Device Catalogue Number: 673662
• Device Lot Number: 152330105X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 01/03/2017
• Supplement Dates Manufacturer Received: 12/07/2016; 08/08/2018
• Supplement Dates FDA Received: 07/18/2018; 10/03/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1