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

Model Number	8884710859
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reports the dobhoff was just placed in a patient and when it was time to pull out the guide wire, they were unable to remove it.They flushed the tube and were still unable to remove the guidewire.The tube had to be removed from the patient and replaced.When the wire was pulled on, the health care provider could see it crinkled the tubing but would not come out.There was no harm to the patient.

• Brand Name: DOBHFF 8FR;43IN W/STYLTY SITE
• 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: 8825851
• Report Number: 9612030-2019-02226
• Device Sequence Number: 2510536
• Product Code: KNT
• UDI-Device Identifier: 10884521518766
• UDI-Public: 10884521518766
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/25/2019

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: 8884710859
• Device Catalogue Number: 8884710859
• Device Lot Number: 625090364X
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1