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

Model Number	461043E
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Additional 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.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 or Problem Description
The customer reported the hub broke and detached on the iris tube.The tube was placed on (b)(6) 2021 and broke on (b)(6) 2021.There was no harm to the patient.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported the hub broke on the iris tube.The tube was placed on 4/27/21 and broke on 5/10/21.The device history record (dhr) review performed found no issues noted during the manufacturing process.The reported device was not returned for evaluation; however, a photograph was provided.Visual inspection of the photograph confirmed the report of detached component as the tubing is detached from the y-port.Manufacturing process and assembly process records were reviewed.Inspection procedures in place require 100% testing prior to product release.Product yield records were reviewed and there were no y-port detachments recorded in production over the past twelve months.A complaint history review performed identified four similar complaint have been received within the past twelve months.A potential root cause for the confirmed detachment is a workmanship issue due to insufficient solvent.A corrective action has been initiated for the installation of a new solvent dispenser for better handling of solvent in the assembly process.Additional action will not be taken a this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 10FR 43 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: 11826990
• Report Number: 1282497-2021-10196
• Device Sequence Number: 4229777
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2021

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: 461043E
• Device Catalogue Number: 461043E
• Device Lot Number: 1043090120
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 09/16/2021
• Patient Sequence Number: 1