inforMED
MalfunctionLIO

VACUTAINER BRAND URINE COLLECTION KIT

Received Oct 14, 1996 · Event occurred Sep 18, 1996

Report 1917413-1996-00001 · MDR key 57154

Device

Generic name

Urine Collection Kit

Model number

NA

Catalog number

4971

Lot number

UNK

Patient

NA

Narrative

Description of Event or Problem

TECHNOLOGIST GOT STUCK WITH THE NEEDLE OF THE URINE COLLECTION KIT COLLECTION CUP WHILE PREPARING IT FOR USE. CUSTOMER FEELS PRODUCT LABELING SHOULD REFLECT THE COLLECTION CUP IS NOT FOR TRANSPORTATION. CUSTOMER WHO COMPLAINED IS AN EXTERNAL REFERENCE LABORATORY. NO MEDICAL TREATMENT WAS GIVEN TO THE TECHNOLOGIST. WOUND SITE WAS CLEANSED, AND BASELINE TESTING WAS GIVEN.