APTIMA SPECIMEN COLLECTION KIT
Received Dec 15, 2015 · Event occurred Nov 17, 2015
Report 2024800-2015-00006 · MDR key 5299566
Device
Product problems
- Unintended Ejection
Patient
Not reported
- Erythema
- Irritation
Narrative
Description of Event or Problem
AN INCIDENT AT (B)(4) OB-GYN OCCURRED WHILE A NURSE WAS COLLECTING SAMPLE FOR THE APTIMA COMBO 2 SWAB SPECIMEN COLLECTION KIT (PN: 301041-01). THE NURSE WAS HOLDING AN OPEN SWAB COLLECTION TUBE FOR THE DOCTOR. THE TUBE WAS HIT WITH HER HAND WHICH EJECTED MATERIAL FROM THE TUBE AND INTO HER EYE. THE APTIMA TUBE DID NOT CONTAIN ANY PATIENT SAMPLE. THE NURSE IMMEDIATELY FLUSHED HER EYES WITH WATER. IT WAS NOTED THAT HER EYE WAS RED AND IRRITATED AFTER IT WAS FLUSHED. A COPY OF THE SAFETY DATA SHEET WAS PROVIDED VIA THE HOLOGIC WEBSITE. THE NURSE WAS SEEN BY AN EYE DOCTOR WHO APPLIED ANTIBIOTIC OINTMENT AND PUT AN EYE PATCH ON THE NURSE FOR 24 HOURS. UPON FOLLOWING UP WITH THE CUSTOMER, SHE HAS INDICATED THAT HER EYE HAS CLEARED UP AND THERE ARE NO VISUAL INDICATION OF INJURY THAT REMAINS.