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

Model Number 461055E

Device Problem Fluid/Blood Leak (1250)

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

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.

Event Description

The customer reported that the port cracked and needed to be replaced.There was no patient injury.Additional information provided on (b)(6) 2021 stated that the feeding tube leaked.

Manufacturer Narrative

The device history record (dhr) is established based on the serial number sticker on the device package.A serial number was not provided, therefore the dhr could not be reviewed.As part of the manufacturing process, all dhrs are reviewed and approved by quality, prior to release of the product.Samples were already used on patient therefore the device/s could not be taken to the production line for evaluation following custom¿s policy therefore a sample evaluation was not able to be performed.A photograph of the device was provided, and a crack is seen on the y-port.The root cause could not be determined based solely on a photographic evaluation.The manufacturing process of the y-port assembly, tests and inspections were reviewed.They performed leak test following product specifications.Based on the available information a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to the current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• 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: 11829232
• MDR Text Key: 250980913
• Report Number: 1282497-2021-10201
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• 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
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/03/2021
• Patient Sequence Number: 1