MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 5 FR X 20; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461412
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2019
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 reported that the tube disconnected between the tube and the connection port prior to feeding when the health care provider was checking for nasogastric tube placement.Due to this the feeding was delayed and the tube had to be replaced.There was no harm to the patient.
Additional Manufacturer Narrative
H 3 : evaluation summary: the device history record (dhr) files were reviewed for the possible lot number reported and no discrepancy was found according to the failure mode reported.Photos and one sample were received for evaluation.After performing a visual inspection, the separation of the purple connector can be observed.The reported condition was confirmed.A corrective and preventative action (capa) was opened to investigate and address the connector disassembly issue.This complaint will be used for tracking and trending purposes.

• Brand Name: POLYUR FEED TUBE 5 FR X 20
• 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: 9489506
• Report Number: 9612030-2019-02376
• Device Sequence Number: 11508549
• Product Code: KNT
• UDI-Device Identifier: 10884521067967
• UDI-Public: 10884521067967
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: 461412
• Device Catalogue Number: 461412
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/11/2019
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1