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

Model Number 711006CN

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer (Section G): COVIDIEN; 15 hampshire street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 11321445
• MDR Text Key: 231597881
• Report Number: 1282497-2021-09908
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521146129
• UDI-Public: 10884521146129
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR