FDA Adverse Event
Summary report: N
CORTRAK 2 ENTERAL ACCESS DEVICE
MDR report key: 3738110
·
Received March 27, 2014
Report
- Report Number
- 3738110
- Date Received
- March 27, 2014
- Date of Event
- February 7, 2014
- Report Date
- March 27, 2014
- Manufacturer
- CORPAK MEDSYSTEMS, INC
- Product Code
- KNT
- Report Source
- User Facility report
- Reporter Location
- VA, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
A SMALL BORE FEEDING TUBE WAS PLACED IN THIS PATIENT USING THE CORTRAK ENTERAL FEEDING TUBE PLACEMENT DEVICE. METHOD OF PLACEMENT WAS CONSISTENT WITH TRAINING AND POLICY. FINAL TRACING FROM CORTRAK DEVICE WAS CONSISTENT WITH DUODENAL PLACEMENT. AFTER OBTAINING KUB AND CHEST X-RAY, IT WAS DETERMINED THAT THE TUBE WAS BRONCHIALLY PLACED. PATIENT WAS IN NO DISTRESS. THE TUBE WAS REMOVED. PATIENT HAD NO PHYSICAL DECOMPENSATION OF THE INTUBATION; HOWEVER, A SMALL APICAL PNEUMOTHORAX WAS SEEN ON THE CHEST FILM, WHICH DID RESOLVE IN APPROXIMATELY 3 DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 182460 | CORTRAK 2 ENTERAL ACCESS DEVICE | CORTRAK 2 ENTERAL ACCESS DEVICE | KNT | CORPAK MEDSYSTEMS, INC | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR |