MAUDE Adverse Event Report: COVIDIEN POLYUR FEED TUBE 5 FR X 36; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	461503
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record could not be completed because the lot number provided by the customer is not a valid lot number.The samples was received outside of the original package and without a valid lot number were received for evaluation.After performing a visual inspection, the separation of the purple connector can be observed in the two samples.The root cause and action plan will be documented through a formal corrective/preventative action which has been initiated to address the ¿connector disassembly¿ condition to mitigate any further occurrences.
Event or Problem Description
Customer reports: the end cap of the feeding tube broke off during use.

• Brand Name: POLYUR FEED TUBE 5 FR 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: 10320075
• Report Number: 9612030-2020-02544
• Device Sequence Number: 3484225
• Product Code: KNT
• UDI-Device Identifier: 10884521067974
• UDI-Public: 10884521067974
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/24/2020

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: 461503
• Device Catalogue Number: 461503
• Device Lot Number: 370229
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1