BROSELOW WHITE INTUBATION MODULE 2PK
Received May 2, 2017 · Event occurred Apr 6, 2017
Report 8030673-2017-00331 · MDR key 6536759
Device
Generic name
Emergency Response Safety Kit
Manufacturer
Carefusion/bdCatalog number
7700WIN
Lot number
11195095
Product problems
- Component Missing
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4).
Description of Event or Problem
CUSTOMER REPORTED THAT THE PRODUCT WAS MISSING TWO ENDOTRACHEAL TUBES. THIS ISSUE WAS DISCOVERED DURING A CODE. THERE WERE TWO NASAL GASTRIC TUBES AND NO ENDOTRACHEAL TUBES.
Additional Manufacturer Narrative
A SAMPLE WAS RECEIVED FOR EVALUATION, THE MISSING COMPONENT WAS CONFIRMED, HOWEVER THE PACKAGING WAS OPEN WHEN RECEIVED. A DHR REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER REPORTED WAS NOT MANUFACTURED AT THE CURRENT FACILITY. TWO-YEARS OF COMPLAINTS WERE REVIEWED AND NO TREND WAS DETECTED. AT THIS TIME IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OF THE MISSING COMPONENT SINCE THE LOT NUMBER REPORTED WAS MANUFACTURED AT A PREVIOUS FACILITY. HOWEVER, THE CURRENT PROCESSES AND PROCEDURES WERE REVIEWED AND NO ISSUES WERE FOUND THAT WOULD CONTRIBUTE TO THIS ISSUE IN THE CURRENT FACILITY. IN ADDITION, THE CURRENT MANUFACTURING PERSONNEL WERE MADE AWARE OF THIS ISSUE.