MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 6.5FR X 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461438
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2019
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.
Event or Problem Description
The customer reported that the device was replaced due to the purple end cap breaking off.There was no patient injury.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One decontaminated sample without the lot number or original packaging was received at the manufacturing site for evaluation.Upon a visual and functional evaluation of the sample, the reported issue was confirmed; the separation of the purple connector was observed.As part of continuous improvements, a formal investigation has been opened to determine the root cause and implement the appropriate corrective actions to prevent the recurrence of the reported issue.This complaint will be used for qa tracking and trending purposes.

• Brand Name: POLYUR FEED TUBE 6.5FR X 36
• 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: 9776499
• Report Number: 9612030-2020-02428
• Device Sequence Number: 2288925
• Product Code: KNT
• UDI-Device Identifier: 10884521067950
• UDI-Public: 10884521067950
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/17/2020

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: 461438
• Device Catalogue Number: 461438
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 04/17/2020
• Patient Sequence Number: 1