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

Model Number	8884710859E
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.
Event or Problem Description
The customer reported that the ng tube had a split at the bifurcation.Additional information received from the customer stated that the tube was broken at the bifurcation during use and leaking was noticed.The ng tube has been replaced.There was no patient harm reported.
Additional Manufacturer Narrative
Emdr evaluation codes: "leaking" code has been added.
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 without original packaging or lot number was received for evaluation.After performing visual inspection per our procedure it was observed that the y-port is broken.By reviewing the process, a root cause could not be determined.Due to the amount of force to damage this equipment, the most likely cause is user misuse.No corrective actions are deemed necessary at this moment.The process is running according to product specifications meeting quality acceptance criteria will be keep monitoring the process for any adverse trends that require immediate attention.

• 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: 9354177
• Report Number: 9612030-2019-02359
• Device Sequence Number: 16667504
• 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,Followup
• Report Date (Section B): 01/23/2020

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?: Yes
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019; 11/15/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 11/21/2019; 01/23/2020
• Patient Sequence Number: 1