inforMED
OtherLSK

TESTPACK CHLAMYDIA

Received Sep 27, 1996 · Event occurred Aug 29, 1996

Report 1451914-1996-00002 · MDR key 55975

Device

Generic name

Rapid Immunoassay For Chlamydia

Model number

NA

Catalog number

3436-18

Lot number

16617M301

Patient

NO INFO

Narrative

Description of Event or Problem

ACCOUNT STATES THAT A NURSING SERVICES COORDINATOR WAS SPLATTERED WITH AN ENDOCERVICAL SAMPLE WHICH WAS MIXED WITH REAGENT A & B OF THE CHLAMYDIA TEST PACK. REAGENT A & B WERE ADDED TO SAMPLE ALONG WITH THE FILTRATION DEVICE. WHEN THE DEVICE CAP WAS OPENED, THE SAMPLE MIXTURE SPLATTERED IN THE EYES AND MOUTH AND ON THE FACE OF THE COORDINATOR PERFORMING THE ASSAY. THE ACCOUNT STATES THERE WAS RESISTANCE AND PRESSURE BUILT UP AS THE PLUNGER WAS PUSHED INTO THE SAMPLE. WHEN THE LID OF THE PLUNGER WAS OPENED, THE MATERIAL SPLATTERED BECAUSE OF BEING UNDER PRESSURE. THE COORDINATOR WAS NOT WEARING GOGGLES AT THE TIME OF THE EVENT. THE NURSING COORDINATOR HAS GONE THROUGH THE CLINIC'S EXPOSURE CONTROL PLAN, HAS BEEN TREATED WITH ANTIBIOTICS, AND WILL RECEIVE THE HEPATITIS VACCINE.