FDA Adverse Event
Death
Summary report: N
ENFIT CORPACK
MDR report key: 17641489
·
Received August 29, 2023
Report
- Report Number
- 17641489
- Event Type
- Death
- Date Received
- August 29, 2023
- Date of Event
- July 1, 2023
- Report Date
- July 14, 2023
- Manufacturer
- CARDINAL HEALTH INC.
- Product Code
- KNT
- Adverse Event
- Yes
- Report Source
- User Facility report
- Reporter Location
- MS, US
- Reporter Occupation
- 501
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2082961 | ENFIT CORPACK | NASOGASTRIC FEEDING TUBE WITH ENFIT CONNECTION | KNT | CARDINAL HEALTH INC. | 8884721088E | 2235412164 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Death |