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	02/19/2020
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.Two decontaminated samples outside of the original package and without a 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
The customer reported that the purple connector had separated from the tubing.

• 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: 10319950
• Report Number: 9612030-2020-02543
• Device Sequence Number: 3484224
• 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: 370237
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 07/24/2020
• Patient Sequence Number: 1