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	04/14/2021
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 kangaroo iris tube broke at the hub.The top of the y port that the cap pushes into, detached from the y port.There was no harm to the patient.
Additional Manufacturer Narrative
A review of the device history record could not be reviewed because there was no serial number provided by the customer.There were no samples provided for evaluation, however a photograph was submitted for evaluation.The reported condition can be observed in the photo however, quality specifications and compliance of the product could not be determined from the photo alone; a physical sample is required to perform a thorough inspection of the device.The reported condition could not be confirmed based solely on the photograph.The reported condition could not be confirmed to be manufacturing related therefore no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• 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: 11680408
• Report Number: 1282497-2021-10068
• Device Sequence Number: 14177995
• Product Code: PIF
• UDI-Device Identifier: 20884521742199
• UDI-Public: 20884521742199
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2021

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 07/16/2021
• Patient Sequence Number: 1