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	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway. upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that during feeding tube use, the purple hub where the syringe connects, falls off of the tube.There was no leaking noticed prior to this occurring.The tubes were only in use for up to two days.There was no patient harm.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Three decontaminated samples were received at the manufacturing site for evaluation.Upon a visual evaluation of the three samples, the reported issue was confirmed.The separation of the purple connector was observed in two of the three samples returned.As part of continuous improvements, a formal investigation was opened to determine the root cause and implement the appropriate corrective actions to prevent the recurrence of the reported issue.This complaint will be used for qa 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: 9623114
• Report Number: 9612030-2020-02397
• Device Sequence Number: 1964892
• Product Code: KNT
• UDI-Device Identifier: 10884521067967
• UDI-Public: 10884521067967
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 02/26/2020

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
• Device Lot Number: 1912738164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2020
• Initial Date Received by Manufacturer: 11/01/2019
• Supplement Date Received by Manufacturer: 11/01/2019
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 02/26/2020
• Patient Sequence Number: 1