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	07/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that formula leaked from the feeding tube's side port during feeding.
Additional Manufacturer Narrative
H 3 sample evaluation: the device history record (dhr) file was reviewed, and no discrepancy was found relating to the failure mode reported.There were no physical samples or pictures submitted with this complaint report.Another complaint from the same customer, for the same product and lot number did have a sample returned for evaluation.From this referred complaint, one decontaminated sample was received.After performing the functional inspection, the condition reported by customer was not observed in the sample.The reported condition was unable to be confirmed.The exact root cause could not be determined at this time.Functional inspection is performed during the manufacturing process with acceptable results according to quality standard requirements.No corrective actions are deemed necessary at this time.The current process is running according to product specifications, meeting quality acceptance criteria.The manufacturing site will continue 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: 10311989
• Report Number: 9612030-2020-02537
• Device Sequence Number: 14296974
• 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): 09/16/2020

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?: No
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 09/16/2020
• Patient Sequence Number: 1