BD URINE COMPLETE CUP SET, BD VACUTAINER

Description of Event or Problem

RECENTLY, MY WIFE PRESENTED AT THE (B)(6) HOSPITAL EMERGENCY DEPARTMENT WITH CLASSIC SYMPTOMS OF URETERAL COLIC. THE INITIAL EVALUATING NURSE APPROPRIATELY ASKED FOR A CLEAN CATCH URINE SAMPLE AND HANDED MY WIFE A COLLECTION SET AFTER TEARING THE PLASTIC WRAP FOR HER. HAVING DIFFICULTY WITH CLOTHES, ETC. IN THE BATHROOM, MY WIFE FOUND THE CUP DIFFICULT TO OPEN. SINCE THE CUP APPEARED TO BE THE SAME TYPE WE HAVE USED FOR YEARS, SHE TRIED PRESSING DOWN ON THE TOP WHILE TWISTING TO OPEN IT. UNEXPECTEDLY, SOMETHING IN THE CUP PIERCED HER FINGER CAUSING BLEEDING. EXAMINATION OF THE CUP SET REVEALED ONLY TINY GRAPHIC INSTRUCTIONS ON THE WRAPPER THAT WE COULD NOT DECIPHER EVEN WITH A MAGNIFIER. I WAS LATER TOLD THAT THIS CUP INCLUDED A DEVICE FOR HANDLING THE SPECIMEN DIFFERENTLY FROM THOSE PLAIN CUPS USED IN THE PAST. MY WIFE'S EXPERIENCE INDICATES THIS DEVICE REPRESENTS A RISK TO UNSUSPECTING PTS. THIS "URINE COMPLETE CUP SET" IS LABELED AS A "BD VACUTAINER" (B)(4).