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

Model Number	8884710859E
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Distal end of dubhoff feeding tube was retained when the tube was removed.It was not discovered right away because the rn was not aware that a weighted end was used and therefore did not know to look for it.

• Brand Name: DOBBHOFF 8FR 43IN W STYLTY
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 19475443
• Report Number: 19475443
• Device Sequence Number: 3981788
• Product Code: KNT
• UDI-Device Identifier: 10884521582880
• UDI-Public: (01)10884521582880(17)280430(10)2313602464
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024
• Report Date (Section F): 05/01/2024

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
• Device Model Number: 8884710859E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/06/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/06/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Date Report Sent to FDA: 05/01/2024