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

Model Number 8884710842

Device Problem Failure to Advance (2524)

Patient Problem Discomfort (2330)

Event Date 03/12/2019

Event Type  Injury  

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 Description

The customer reports the feeding tube was introduced normally by nasal insertion into a patient that was endotracheally intubated, on mechanical ventilation at that time.The tube coiled and formed a knot inside the patient during the insertion process without the nurse becoming aware.An x-ray did not reveal the tube so it was assumed it had coiled in the pharynx or mouth.The patient's oral cavity was examined, and the tube was not seen in the mouth.The health care provider proceeded to pull on the tube, but it was stuck.Enough pull force was applied which warranted stopping the attempt and a bronchoscopy was performed, inserting the bronchoscope via the opposite nostril which found the tube had been anchored at the choana because the knot was larger than the size of the choana.The tube was then advanced into the hypopharynx and fished out the mouth.The knot was untied and the tube was then successfully pulled from the nose.The patient did not experience any harm beyond some shortly-lived nasal bleeding, which required no additional intervention.The bronchoscopy caused some discomfort but there were no complications with the procedure.

Manufacturer Narrative

A review of the device history record could not be conducted because a lot number was not provided.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.A physical sample was not returned for the investigation however a photo was provided.A visual evaluation of the photo confirmed the reported issue, the tube was bent (tangled).Without evaluating the physical sample, the root cause could not be identified.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: DOBBHOFF 8FR;43IN W/O STYLET
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 8510363
• MDR Text Key: 141796690
• Report Number: 9612030-2019-02150
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8884710842
• Device Catalogue Number: 8884710842
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/08/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other