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

Model Number 461043E

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

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

Event Date 03/03/2021

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that 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.  if additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

The customer reported that when attempting to change the tubing, the tube feed seemed to have hardened around the port.When attempting to unscrew the tubing, the rubber portion of the dobhoff ripped, and the top plastic part came off with the tubing.They were unable to continue tube feeds and the port was leaky.

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.Since a sample was not returned for evaluation and no photos were provided, a product failure analysis could not be performed, and a root cause of the reported issue was unable to be determined.The manufacturing process of the y-port assembly, tests and inspections were reviewed.All devices are 100% tested and inspected prior to release.Although the root cause of the reported issue was not be determined, corrective actions were recently implemented; a new solvent dispenser was put into service, and the structure of the y-port design change has been made from the wing design to a no-wing design because the no-wing design will increase the surface area of the bond and has been proven to increase the bond strength of the y-port assembly.Functional testing and visual inspections are being performed according to the current quality standards and inspection procedures.If a sample is received, this complaint will be reopened for further investigation.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: 11740144
• MDR Text Key: 248204742
• Report Number: 1282497-2021-10123
• 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: 07/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 04/28/2021
• Supplement Dates Manufacturer Received: 04/14/2021
• Supplement Dates FDA Received: 07/12/2021
• Patient Sequence Number: 1