MAUDE Adverse Event Report: COVIDIEN PVC FEEDING TUBE 8FRX42"

Model Number 460406

Device Problems Crack (1135); Insufficient Flow or Under Infusion (2182); Inaccurate Delivery (2339); Improper Flow or Infusion (2954)

Patient Problem Feeding Problem (1850)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/03/2016.An investigation is currently underway.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 feeding tube.The customer reports that the feeding tube was placed for feeding of a newborn.The infant was given their first tube feeding and the tubing did not permit proper flow, it was very restricted and slow in rate of infusion.The staff states that they must put some pressure behind the infuse feeding.Ultimately, for the second feeding the fluids would not run so the tube was removed.When the tube was removed, the staff discovered that the tubing a cracked and split practically through the entire tube.

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 defect and root cause analysis.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa 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: PVC FEEDING TUBE 8FRX42"
• Type of Device: FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• MDR Report Key: 6076607
• MDR Text Key: 59455067
• Report Number: 9612030-2016-00603
• Device Sequence Number: 1
• Product Code: FPD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 460406
• Device Catalogue Number: 460406
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/08/2018
• Patient Sequence Number: 1