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

Model Number	461055E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: GASTROINTESTINAL TUBES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11829232
• Report Number: 1282497-2021-10201
• Device Sequence Number: 4242496
• Product Code: PIF
• UDI-Device Identifier: 20884521742205
• UDI-Public: 20884521742205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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
• Operator of Device: No Information
• Device Model Number: 461055E
• Device Catalogue Number: 461055E
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 05/03/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 08/24/2021
• Patient Sequence Number: 1