MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 8FR;43IN W/STYLTY SI; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	8884710859E
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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
The customer reported that there is leaking from base of enfit connection port.
Additional Manufacturer Narrative
Since a lot number was not provided, the device history record could not be performed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was received for the evaluation.Upon a functional inspection of the sample, the reported condition is not confirmed.The root cause of the reported condition could not be determined.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: DOBBHOFF 8FR;43IN W/STYLTY SI
• 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: 9124447
• Report Number: 9612030-2019-02288
• Device Sequence Number: 2820030
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: 10884521582880
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 01/24/2020

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: 8884710859E
• Device Catalogue Number: 8884710859E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 09/19/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1