MAUDE Adverse Event Report: COVIDIEN GSTRO FEED TBE W/Y PRT 12FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884715122
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2019
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 that the gastronomy feeding tube was leaking.There was no harm to the patient.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Two samples were received for the evaluation.It is not possible to confirm the reported condition at this time.This catheter is a purchased component with part number (b)(4) and is supplied by an external supplier.A complaint notification and the samples were sent to supplier to initiate the investigation of root cause and determine the corrective action regarding the reported issue.

• Brand Name: GSTRO FEED TBE W/Y PRT 12FR
• 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: 8836524
• Report Number: 9612030-2019-02230
• Device Sequence Number: 11391478
• Product Code: KNT
• UDI-Device Identifier: 10884521007154
• UDI-Public: 10884521007154
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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: 8884715122
• Device Catalogue Number: 8884715122
• Device Lot Number: 1819805164
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 07/12/2019
• Initial Report FDA Received Date: 07/29/2019
• Supplement Report FDA Received Date: 11/22/2019
• Patient Sequence Number: 1