APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT
Received Apr 6, 2016 · Event occurred Mar 11, 2016
Report 2024800-2016-00008 · MDR key 5552786
Device
Generic name
In-vitro Diagnostic Assay
Manufacturer
Hologic, Inc.Model number
301162Catalog number
301162
Product problems
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Exposure to Body Fluids
- Exposure to Body Fluids
Narrative
Description of Event or Problem
AN INCIDENT OCCURRED AT (B)(6) WHERE A SWAB SAMPLE WAS INCORRECTLY PLACED INTO THE VAGINAL COLLECTION TUBE. INSTEAD OF OPENING THE COLLECTION TUBE AND PLACING THE SWAB INSIDE, THE SWAB WAS PUSHED THROUGH THE PENETRABLE CAP. IN AN ATTEMPT TO REMOVE THE SWAB, A TECHNICIAN PULLED THE SWAB OUT CAUSING A SPLASH AND MEDIA GOT INTO HER EYE. THE TECHNICIAN WAS NOT WEARING ANY SAFETY GOGGLES OR SAFETY SHIELD. THE TECHNICIAN WAS TAKEN TO THE EMERGENCY ROOM WHERE HER EYES WERE RINSED THOROUGHLY WITH WATER. UPON FOLLOWING UP, THE TECHNICIAN WAS TAKEN TO THE DOCTOR AND HAD HER EYE EXAMINED. SHE IS DOING FINE, AND NO ISSUES WERE FOUND.