MAUDE Adverse Event Report: COVIDIEN UNWTD KANG FEED TUBE 14FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711519
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2020
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 formula leaked from the side port during feeding.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One decontaminated sample was received for evaluation.After performing the functional inspection, the condition reported by customer was not observed in the sample.Since the issue reported was not confirmed, the exact root cause could not be determined at this time.Functional inspections are performed during the manufacturing process with acceptable results according with quality standard requirements.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: UNWTD KANG FEED TUBE 14FR
• 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: 10312012
• Report Number: 9612030-2020-02539
• Device Sequence Number: 3427112
• Product Code: KNT
• UDI-Device Identifier: 10884521009691
• UDI-Public: 10884521009691
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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): 09/21/2020

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: 8884711519
• Device Catalogue Number: 8884711519
• Device Lot Number: 1920806364
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/09/2020
• Supplement Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/21/2020
• Patient Sequence Number: 1