InjuryLSL
APTIMA VAGINAL SWAB SPECIMEN COLLECTION KIT
Received Oct 29, 2014 · Event occurred Sep 25, 2014
Report 2024800-2014-00004 · MDR key 4211640
Device
Generic name
In-vitro Diagnostic Assay
Manufacturer
Hologic, Inc.Model number
301162Catalog number
301162
Lot number
108908A
Product problems
- Unintended Ejection
- Material Fragmentation
- Improper or Incorrect Procedure or Method
Patient
Not reported
- Eye Injury
- Distress
Narrative
Description of Event or Problem
GP HAVING TAKEN NORMAL VAGINAL SWAB WAS TRANSFERRING TO THE TRANSPORT TUBE AND "BREAKING" THE HEAD WITHIN THE TUBE RATHER THAN BREAKING IN ITS DESIGNED SPOT, THE PINK HANDLE BROKE IN TWO PLACES WITH A ONE CM PART FLYING BACK UP WITH SOME FORCE INTO THE GP'S EYE CAUSING DISTRESS TO HER. MAIN PART OF THE SWAB SAMPLE REMAINED IN BOTTLE, MAIN PART OF STEM IN HAND. THE USER TOOK STEPS TO IRRIGATE EYE IN CASE OF LOCAL CONTAMINATION.