MAUDE Adverse Event Report: COVIDIEN UNWTD KANG FEED TUBE 12FR; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884711501
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
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 the feeding tube's cap found loose after a few days resulting in the leak of the feeding formula.
Additional Manufacturer Narrative
One unused sample with lot number 1726921264 was received for evaluation.After performing the functional inspection, the condition reported by customer was not observed.The device history record file was reviewed and no discrepancy was found according to the failure mode reported.Since the sample received was analyzed and the condition reported was not observed in the product the root cause could not be determined.Functional inspections are performed during the manufacturing process with acceptable results according with quality standard requirements.At this time no corrective actions are deemed necessary since the reported condition could not be confirmed.We will keep monitoring the process for any adverse trends that require immediate attention.

• Brand Name: UNWTD KANG FEED TUBE 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: 8816945
• Report Number: 9612030-2019-02222
• Device Sequence Number: 3027602
• Product Code: KNT
• UDI-Device Identifier: 10884521009684
• UDI-Public: 10884521009684
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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): 10/31/2019

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: 8884711501
• Device Catalogue Number: 8884711501
• Device Lot Number: 1726921264
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1