FDA Adverse Event Injury Summary report: N

KENDALL ARGYLE

MDR report key: 1211155 · Received October 24, 2008

Report

Report Number
1211155
Event Type
Injury
Date Received
October 24, 2008
Date of Event
September 12, 2008
Report Date
October 23, 2008
Manufacturer
COVIDIEN
Product Code
JOL
Product Problem
Yes
Report Source
User Facility report
Reporter Location
NY, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

WHILE THE NURSE WAS SUCTIONING THE PT, THE PT BROKE OFF THE TIP OF THE YANKAUER SUCTION TUBE. THE GASTROENTEROLOGIST WAS CALLED AND HE RETRIEVED THE PIECE THAT MEASURED 4.5 X 1 X 0.8 CM. THE PT TOLERATED THE PROCEDURE WITH NO FURTHER SEQUELAE. TIP SENT TO PATHOLOGY TO ASSESS WHETHER PROD DEFECT, INDETERMINATE. AFTER REVIEW, IT WAS DECIDED TO REPORT.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 KENDALL ARGYLE YANKAUER SUCTION TUBE JOL COVIDIEN 8888505016

Patients

Seq Age Sex Outcome Treatment
1 78 YR Life Threatening