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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the proximal third of the tugsten tip probe is observed.There was a leakage of the liquid at the key junction and the body of the probe which safely prevents the administration of nutritional support.

• 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: 10384740
• Report Number: 9612030-2020-02557
• Device Sequence Number: 1712579
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: 10884521582880
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/10/2020

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
• Device Lot Number: 183601264
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/10/2020
• Patient Sequence Number: 1