MAUDE Adverse Event Report: COVIDIEN 10FR 55 IRIS FEEDING TUBE ENF; GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS

Model Number 461055E

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2020

Event Type  malfunction  

Manufacturer Narrative

The device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

During a visit to the facility, the sales representative observed an iris placement.The feeding tube was placed by nurse (b)(6).Upon confirmation via a kub, the nurse was unable to remove the stylet.Even after the removal of the feeding tube the stylet still could not be removed.There was no patient injury.

Manufacturer Narrative

A device history record review could not be performed because a serial number was not received with the complaint.The lot number provided is used to track the manufacturing date and expiration date only.The device history record is established based on a serial number that is on the device.Without the serial number, the device history record could not be reviewed.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A physical sample was not received for the investigation due to it being used with a covid patient, but a photo was provided for a visual analysis.The photo was analyzed, and the tube was observed to be bent.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to determine the root cause.The production line was reviewed, and all stylets were found to be well packed in bags.The assembly process was reviewed and found that the tube is placed straight on the fixture and there is no risk of the tube or stylet becoming deformed during the stylet assembly process.The tube packaging process was also reviewed, the tube is coiled and placed in a plastic tray, there is no risk of the tube or stylet becoming deformed during the packaging process.The review did not find any abnormal processes during the manufacturing process that could have contributed to the reported condition.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 tracking and trending purposes to determine the need for corrective actions.

• Brand Name: 10FR 55 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: 10574995
• MDR Text Key: 208184961
• Report Number: 1282497-2020-09468
• Device Sequence Number: 1
• Product Code: PIF
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• 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: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Device Lot Number: 1055112018
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Patient Sequence Number: 1