MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 6.5FR X 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461438
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	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation because it was discarded; 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.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 the purple top came apart from the tube without any force on the product.
Additional Manufacturer Narrative
A review of the device history record could not be conducted because a lot number was not provided.Two photographs and one decontaminated sample outside of the original package and without a lot number was received for evaluation.After a visual inspection, the separation of the purple connector can be observed.The reported condition has been confirmed.A formal investigation was opened in order to determine the root cause and implement the appropriated corrective action(s).

• Brand Name: POLYUR FEED TUBE 6.5FR X 36
• 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: 9354213
• Report Number: 9612030-2019-02360
• Device Sequence Number: 2648403
• Product Code: KNT
• UDI-Device Identifier: 10884521067950
• UDI-Public: 10884521067950
• 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: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2020

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: 461438
• Device Catalogue Number: 461438
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 01/16/2020
• Patient Sequence Number: 1