MAUDE Adverse Event Report: COVIDIEN 12 FR X 55 ENTRIFLEX W/STYLET; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721255

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; 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

Customer reports: the welding point of the interface leaked.

Manufacturer Narrative

A device history record could not be performed because a lot number could not be provided by the customer.A product analysis was unable to be completed as to date no samples have been provided.Two digital images were provided for analysis.The analysis of the sample was carried out using the digital image provided by the client; but it was not possible to confirm the reported condition of a leakage of the device based solely on the photograph.Based on the information available and the investigation findings, a formal investigation is not deemed necessary at this time.The reported condition could not confirm a manufacturing deficiency.If additional information is received warranting further analysis, the investigation may be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 12 FR X 55 ENTRIFLEX W/STYLET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10404161
• MDR Text Key: 202802669
• Report Number: 9612030-2020-02566
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/05/2020

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
• Device Operator: No Information
• Device Model Number: 8884721255
• Device Catalogue Number: 8884721255
• Initial Date Manufacturer Received: 08/13/2020
• Initial Date FDA Received: 08/13/2020
• Supplement Dates Manufacturer Received: 08/13/2020
• Supplement Dates FDA Received: 10/05/2020
• Patient Sequence Number: 1