MAUDE Adverse Event Report: COVIDIEN ENTFLX 12FR;43IN W/STYL YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721252

Device Problem Difficult to Remove (1528)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Additional information was requested to clarify the reported incident however due to the current covid19 pandemic, no further details have been provided by the customer as of yet.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 Description

The customer reported that there was difficulty in removing the guidewire.

• Brand Name: ENTFLX 12FR;43IN W/STYL YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10086573
• MDR Text Key: 192051472
• Report Number: 9612030-2020-02471
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518919
• UDI-Public: 10884521518919
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884721252
• Device Catalogue Number: 8884721252
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1