MAUDE Adverse Event Report: COVIDIEN DOBBHOFF 10FR;43IN W/ STYLECN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	711006CN
Medical Device Problem Codes	Partial Blockage (1065); Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2020
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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported a kangaroo co2 detector was placed on the patient.There was constant difficulty when flushing the device or unable to flush the device at all.A new kangaroo co2 detector was opened to replace the affected one and the same problem occurred with the new device.An xray showed that the kangaroo co2 detector was in the proper position even when pulled back a little.This occurred over two days.This report is for one of the two days.After the failures with the kangaroo co2 detectors, a nasogastric tube was placed on the patient and they were able to start tube feeding.

• Brand Name: DOBBHOFF 10FR;43IN W/ STYLECN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11321391
• Report Number: 1282497-2021-09907
• Device Sequence Number: 19693719
• Product Code: KNT
• UDI-Device Identifier: 10884521146129
• UDI-Public: 10884521146129
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/12/2021

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 Expiration Date: 08/01/2021
• Device Model Number: 711006CN
• Device Catalogue Number: 711006CN
• Device Lot Number: 200970201
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 02/12/2021
• Patient Sequence Number: 1
• Patient Age: 76 YR