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

Model Number	461355
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/11/2020
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 reported that the cap separated from the tubing.There was no patient injury.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) files were reviewed, and no discrepancy was found relating to the failure mode reported.There were no physical samples or pictures submitted with this complaint report.The complaint will be reopened if a sample is received.The reported condition was unable to be confirmed.The root cause could not be determined; however, due to previous complaints reported with the same issue, a formal corrective and preventative action (capa) was opened to determine the root cause and implement the appropriated corrective action(s).This complaint will be used for tracking and trending purposes.

• 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: 9829342
• Report Number: 9612030-2020-02434
• Device Sequence Number: 16325604
• 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: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2020

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: 1911339964
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/03/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1