FDA Adverse Event Summary report: N

CBC II

MDR report key: 517835 · Received March 22, 2004

Report

Report Number
2648666-2004-20003
Date Received
March 22, 2004
Report Date
February 4, 2004
Manufacturer
STRYKER INSTRUMENTS
Product Code
CAC
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
FL, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

SURGEON ATTEMPTED TO REMOVE DRAIN AND DRAIN BROKE OFF. ADDITIONAL SURGERY WAS REQUIRED FOR REMOVAL OF FOREIGN BODY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CBC II APPARATUS, AUTO TRANSFUSION CAC STRYKER INSTRUMENTS 0225-028-914 NA

Patients

Seq Age Sex Outcome Treatment
1 * Required Intervention