MAUDE Adverse Event Report: CARDINAL HEALTH ENTRFLX 10FR 43IN W STY YPORT; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 8884721088E

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypoxia (1918); Pneumothorax (2012)

Event Date 10/25/2023

Event Type  Death  

Event Description

The customer reported that a 10fr/43in dobbhoff was inserted in the patient.After placement, the x-ray confirmed it was located in the right lung.The patient became distressed.The tube was removed and a chest tube was placed.The patient deteriorated and passed away later that day.It was determined the patient suffered from a pneumothorax and was not able to recover due to other comorbidities.They made the decision to pull the 10fr tube from the floors thinking it could be a product issue.Per additional information received, when the dobhoff was inserted, there was no resistance or difficulty, and the nurse could not hear anything with auscultation and removed it.There were no identifiable or visible defect on the device.The sequence of events are as a follows: the patient removed the feeding tube and the nurse replaced with 10 fr nasogastric feeding tube.There was a sudden onset of respiratory distress and hypoxia.A stat x-ray was obtained, and pneumothorax was noted.A surgeon was present, and a chest tube was placed emergently.The patient initially rebounded but then declined.The family was at bedside and a decision was made to change the patient status to dnr with treatment.The patient expired despite intervention of levophed, atropine, and epi.They went into pea (pulseless electrical activity) at 3:54 a.M.On (b)(6) 2023.The patient had a history of chf (congestive heart failure) and respiratory failure.The patient was in the cicu at one time and was on the vent.They had a long standing trach.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

Samples were not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: ENTRFLX 10FR 43IN W STY YPORT
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18176955
• MDR Text Key: 328609840
• Report Number: 9612030-2023-03867
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521582996
• UDI-Public: 10884521582996
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 8884721088E
• Device Catalogue Number: 8884721088E
• Device Lot Number: 2305701164
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 10/26/2023
• Supplement Dates FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death