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

Model Number	8884721255
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Customer reports: the welding point of the interface leaked.
Additional 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
• 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: 10404161
• Report Number: 9612030-2020-02566
• Device Sequence Number: 19564076
• Product Code: KNT
• UDI-Device Identifier: 10884521518926
• UDI-Public: 10884521518926
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: No Information
• Device Model Number: 8884721255
• Device Catalogue Number: 8884721255
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1