MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 3.5 FR X 12; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461355
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2019
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reports the connector detached from the feeding tube leaving part of the tube outside of the patient.The nurse removed the tubing with their fingers the same as any other feeding tube removal.No medical intervention was required.The feeding tube was originally placed on (b)(6) 2019.
Additional Manufacturer Narrative
There were no physical samples submitted with the complaint report.One picture was submitted for investigation.Based on the picture it was not possible to confirm the issue reported by our customer.The device history records (dhr) files were reviewed and no discrepancy was found according to the failure mode reported.The root cause could not be determined by evaluating the picture received.No corrective and preventative actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria.The manufacturing plant will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: POLYUR FEED TUBE 3.5 FR X 12
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8704748
• Report Number: 9612030-2019-02202
• Device Sequence Number: 16667044
• Product Code: KNT
• UDI-Device Identifier: 10884521067394
• UDI-Public: 10884521067394
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2019

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: 461355
• Device Catalogue Number: 461355
• Device Lot Number: 1900925964
• Initial Date Received by Manufacturer: 06/06/2019
• Supplement Date Received by Manufacturer: 06/06/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 10/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 2