PORTEX MINI-TRACH II - NON SELDINGER KIT
Received Apr 4, 2018 · Event occurred Mar 1, 2018
Report 3012307300-2018-00663 · MDR key 7396086
Device
Generic name
Cricothyrotomy Kit
Manufacturer
Smiths Medical, Asd, Inc.Catalog number
100/461/000
Lot number
3457249
Product problems
- Positioning Failure
- Positioning Failure
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(6).
Description of Event or Problem
IT WAS REPORTED THAT AFTER INDWELLING A TUOHY NEEDLE IN A PATIENT, THE CUSTOMER ATTEMPTED TO INSERT THE GUIDEWIRE INTO IT; BUT COULDN'T WITH THE USE OF A PORTEX® MINI-TRACH® II - NON SELDINGER KIT. NO PATIENT INJURY.
Additional Manufacturer Narrative
ONE TUOHY NEEDLE AND ONE GUIDE WIRE WERE PROVIDED FOR EVALUATION. THE NEEDLE WAS TESTED AND FOUND TO BE INSERTED WITHOUT RESISTANCE. THE GUIDE WIRE WAS TESTED AS WELL, AND UPON INSERTION WAS NOT FOUND TO HAVE RESISTANCE. EVERY NEEDLE RECEIVED AT SMITHS MEDICAL (B)(4) GETS INSPECTED RANDOMLY AND THERE HAVE BEEN NO DEVIATIONS IN THE INSPECTION PROTOCOL OF THE INVOLVED NEEDLE LOTS. THE REPORTED COMPLAINT WAS NOT CONFIRMED AND REVEALED NO INTRINSIC EVIDENCE TO SUGGEST A ROOT CAUSE RELATED TO MANUFACTURING.