CATHETER 5FR CLOSED FLUID ACCESS 50/CS
Received Mar 8, 2018 · Event occurred Jan 11, 2018
Report 2050001-2018-00094 · MDR key 7325178
Device
Generic name
Catheters, Suction, Tracheobronchial
Manufacturer
Pacific Hospital Supply Co., LtdCatalog number
CSC205S
Lot number
16019522
Product problems
- Material Separation
- Material Separation
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
VYAIRE HAS REACHED OUT TO CUSTOMER TO PROVIDE ADDITIONAL INFORMATION REGARDING THE REPORTED ISSUE, ALONG WITH THE AFFECTED SAMPLE FOR FURTHER INVESTIGATION. AT THIS TIME VYAIRE IS WAITING FOR A CUSTOMER RESPONSE .IF THE CUSTOMER PROVIDES THE SAMPLE FOR FURTHER INVESTIGATION OR ADDITIONAL INFORMATION IS OBTAINED, VYAIRE WILL PROVIDED A FOLLOW UP EMDR.
Description of Event or Problem
PER MED WATCH REPORT MW5075085: "ADMINISTERING CUROSURF IN OR POST DELIVERY. FIRST DOSE WENT IN FINE. SECOND DOSE CATHETER BROKE, LOST 8 CM OF CATHETER IN ET TUBE. RECOVERED BROKEN PART OF CATHETER WITH MECONIUM CATHETER/ASPIRATOR PER PHYSICIAN AT BEDSIDE".