MAUDE Adverse Event Report: COVIDIEN ENTERAL FEEDING UNKNOWN; ENTERAL FEEDING BAG

Model Number UNKNOWN

Device Problems Insufficient Flow or Under Infusion (2182); Device Operates Differently Than Expected (2913); Free or Unrestricted Flow (2945); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/14/2016.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 a enteral feeding bag.Customer reports: we have had constant issues with the drip either going full blast or it just stops dripping.Someone constantly has to sit by her and monitor the feeding so it is not either pouring in or not dripping at all.There is no in between unless someone is sitting with a thumb on the wheel at all times.Customer is not sure of the product number but the description is 1000ml gravity drip enteral feeding bags.Customer states she has not had bags that have not had issues for well over a year, so she states that dozens if not hundreds of bags have had this issue.The customer states that the control valve that looks like a wheel is what she is referring to.If someone is not monitoring the wheel / valve it is either full open flow and the feeding happens way to quickly, or the flow stops entirely, so someone has to sit and watch it carefully at all times.There is no occlusion as far as she can tell.Customer states that her daughter is not underfed because someone is always monitoring the feeding to adjust the bags if needed.The formula being used is pedicure 1.5 calorie.She is not diabetic.There has not been patient harm but the products faultiness is resulting in mass-frustration and time wasted by anyone who is in charge of providing her tube feedings.

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.

• Brand Name: ENTERAL FEEDING UNKNOWN
• Type of Device: ENTERAL FEEDING BAG
• Manufacturer (Section D): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana
• Manufacturer (Section G): COVIDIEN; 37 blvd. insurgentes libriamento; a la p, la mesa; tijuana
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6099146
• MDR Text Key: 60291759
• Report Number: 1282497-2016-00910
• 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: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1