MAUDE Adverse Event Report: CARDINAL HEALTH INC. ENFIT CORPACK; NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTION

Model Number 8884721088E

Patient Problem Pneumothorax (2012)

Event Date 07/01/2023

Event Type  Death  

Event Description

On the morning on july 1st, two attempts to place a corpak were made.Both attempts ended up in the lungs.The sicu fellow used a ng tube for the 3rd attempt, and was able to place the tube in the gastric body.A couple hours later the patient experienced cardiac arrest.And code blue response initiated.Patient was found to have a pneumothorax.Presumptively caused by the failed corpak placements.Family decided to pursue comfort measures, and patient passed on the 3rd.

• Brand Name: ENFIT CORPACK
• Type of Device: NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTION
• Manufacturer (Section D): CARDINAL HEALTH INC.; dublin OH
• MDR Report Key: 17641489
• MDR Text Key: 322225795
• Report Number: 17641489
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/14/2023

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: 884721088E
• Device Lot Number: 2235412164
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/14/2023
• Distributor Facility Aware Date: 07/14/2023
• Device Age: MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White