MAUDE Adverse Event Report: COVIDIEN 10FR 43 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461043E

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/01/2020

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.

Event Description

The customer reported that when attaching the iris feeding tube to the interface cable the light did not turn on and there was no image visible on the screen.After further attempts and opening more tubes, the light went on and visualization on the console was possible.Mid-placement, the screen turned black and the tube would not reconnect.No patient injury was reported.Additional information provided on (b)(6) 2020 stated that the screen would turn on and work then go black.They switched cables and tubes and the problem continued until they used tubes from a different lot number.Then it worked fine.

Manufacturer Narrative

Based on the given serial number information, fg level build history was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all history records are reviewed and approved by quality, prior to release of product.The sample was not received at the manufacturing site due to the customs policy; therefore, the product evaluation could not be performed.However, a photo was provided for the evaluation.Upon visual evaluation, the reported condition is not confirmed.According to the supplier, line touring performed on manufacturing process, there are four stations that can test the tube display, pre-power up station before uv gluing, power up station after uv gluing, fvt2 after over-molding and post-power up station, before packaging.All tubes have been 100% tested by the four stations before packaging.The tubes could not be packaged, if they were declined at any test station.From the investigation, no abnormal display found during manufacturing process, therefore the definite root cause could not be determined.A corrective action is not applicable at this time.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 10FR 43 IRIS FEEDING TUBE ENF
• Type of Device: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11041527
• MDR Text Key: 222549288
• Report Number: 1282497-2020-09802
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• 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: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461043E
• Device Catalogue Number: 461043E
• Device Lot Number: 1043050119
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/01/2020
• Patient Sequence Number: 1