MalfunctionOGP
PORTEX MINI-TRACH II - NON SELDINGER KIT
Received May 15, 2018 · Event occurred Apr 15, 2018
Report 3012307300-2018-01420 · MDR key 7514077
Device
Product problems
- Bent
- Bent
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
INFORMATION WAS RECEIVED INDICATING THAT DURING USE WITH A PATIENT, A GUIDEWIRE TO A SMITHS MEDICAL PORTEX® MINI-TRACH® II - NON SELDINGER KIT WAS FOUND TO BE BENT. THERE WERE NO REPORTED ADVERSE EFFECTS.
Additional Manufacturer Narrative
THE INVESTIGATION WAS UNABLE TO BE PERFORMED BECAUSE THE GUIDEWIRE WAS NOT RETURNED WITH THE SAMPLE. ADDITIONALLY, A TREND ANALYSIS EVALUATION WAS NOT POSSIBLE BECAUSE THE LOT NUMBER OF THE PRODUCT WAS NOT PROVIDED. THIS INVESTIGATION REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.