inforMED
InjuryLSL

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

301162

Catalog 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.