MAUDE Adverse Event Report: COVIDIEN UNKNOWN ENTERAL ACCESS; NASAL GASTRIC FEEDING TUBE

Model Number UNK EA

Device Problem Positioning Problem (3009)

Patient Problems Cardiopulmonary Arrest (1765); Pneumothorax (2012); Low Oxygen Saturation (2477)

Event Date 04/04/2015

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a feeding tube.The customer states the patient underwent a dobhoff tube placement at bedside.An x-ray was ordered but never performed to confirm placement of the tube.Within five minutes after tube placement the patient began to decompensate.The ventilator alarm sounded and the clinical staff attended to the patient immediately.Patients sats dropped in the 70s.The dobhoff tube was removed and the patient began to return to her normal baseline.Several minutes later the patients alarms begin to sound again as she was decompensating.The patient became unresponsive and a code blue was called.Post code readings of the tube placement x-rays were received after the code which revealed a pneumothorax on the left side.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.(b)(4).

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.There were no samples received for evaluation.Because a sample was not available for evaluation, a root cause analysis could not be conducted to determine the root cause of this reported issue.The most probable root cause can be due to advertent bronchopulmonary displacement.Pneumothorax of the nasal or oral enteric feeding tubes can be caused by complication of current placement techniques for blindly placing the nasal or oral enteric feeding tubes.Per the instructions for use, a warning provides adverse effects like pneumothorax, intestinal perforation and aspirational pneumonia have been reported during the use of this type of device, therefore due to the extreme caution this device should only be inserted by a trained clinician.The process to manufacture the device was running according to the defined parameters and specifications.The products met the corresponding quality acceptance criteria.The production personnel were notified about the reported issue.A corrective action is not applicable at this time.Covidien will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: UNKNOWN ENTERAL ACCESS
• Type of Device: NASAL GASTRIC FEEDING TUBE
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad; industrial; tijuana ; MX
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125; cuidad industrial; tijuana ; MX
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4765772
• MDR Text Key: 5791457
• Report Number: 9612030-2015-00053
• Device Sequence Number: 1
• Product Code: FPD
• 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,other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK EA
• Device Catalogue Number: UNK EA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR