FDA Adverse Event Summary report: N

N-PAK

MDR report key: 2502115 · Received March 9, 2012

Report

Report Number
2502115
Date Received
March 9, 2012
Date of Event
February 16, 2012
Report Date
March 9, 2012
Manufacturer
M-PRO
Product Code
ENW
Report Source
User Facility report
Reporter Location
NC, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

NURSE IN ROOM TO PERFORM RSV TEST WITH NASOPHARYNGEAL ASPIRATION KIT. THE TIP OF THE TUBE CAME OFF IN PATIENT'S LEFT NARE WHEN THE BABY WAS CRYING, WHICH RESULTED IN THE TUBING BEING SUCKED IN THE PATIENT'S NOSE. A DOCTOR ATTEMPTED TO GET IT OUT. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL. ANOTHER DOCTOR CALLED INTO RETRIEVE TIP AND WAS SUCCESSFUL. THE TUBE WAS REMOVED INTACT AND THERE WAS NO HARM DONE TO THE PATIENT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 N-PAK CATHETER, NASOPHARYNGEAL ENW M-PRO * 042229409

Patients

Seq Age Sex Outcome Treatment
1 5 MO