PORTEX SUCTIONPRO 72 SUCTION SYSTEM
Received Jun 18, 2020 · Event occurred Mar 31, 2020
Report 3012307300-2020-06062 · MDR key 10171194
Device
Product problems
- Break
- Material Fragmentation
- Break
- Material Fragmentation
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT FOLLOWING SUCTIONING A PATIENT WITH A SMITHS MEDICAL PORTEX SUCTION PRO 72 CLOSED SUCTION SYSTEM, THE WHITE PART WAS FOUND BROKEN AND THE SLEEVE CAME OFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Additional Manufacturer Narrative
OTHER, OTHER TEXT: ONE CATHETER WAS RETURNED FOR EVALUATION. VISUAL INSPECTION OF THE DEVICE FOUND THE SLIP COLLET TO BE BROKEN. 32 SAMPLES WERE THEN TAKEN FROM THE PRODUCTION FLOOR AND INSPECTED TO VERIFY COMPONENTS WERE UNDAMAGED. NO DISCREPANCIES WERE FOUND. FOUR SAMPLES FROM THE MENTIONED LOT UNDERWENT FUNCTIONAL TESTING BY APPLYING FORCE TO THE SLIP COLLET; NO DISCREPANCIES WERE NOTED. THE REPORTED CUSTOMER COMPLAINT HAS BEEN CONFIRMED AND THE PROBLEM SOURCE HAS BEEN DETERMINED TO BE UNKNOWN.