AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SY

Description of Event or Problem

CUSTOMER WAS SQUEEZING THE ATTS AMPULE AND A PIECE OF GLASS PIERCED THE PLASTIC AND INJURED THE TECH'S FINGER. SHE WAS GIVEN BASIC FIRST AID AND SENT TO A WORKMAN'S COMP FACILITY. THEY LANCED HER FINGER TO REMOVE GLASS THAT WAS STILL THERE AND GAVE HER ANTIBIOTICS AS A PRECAUTION. THE TECH CALLED OUT OF WORK THE NEXT DAY DUE TO THE PAIN AND COMMENTED REGARDING A QUESTION OF WHETHER THERE WAS DAMAGE TO THE TENDON WHICH MAY REQUIRE PHYSICAL THERAPY.

Additional Manufacturer Narrative

THIS PRODUCT CONTAINS AN AMPULE OF REAGENT. THE AMPULE IS CRUSHED AND THE REAGENT IS RELEASED THROUGH A DROPPER INTO A PT SAMPLE. THE CUSTOMER WAS UNABLE TO PROVIDE A SPECIFIC LOT NUMBER OF PRODUCT WHICH WAS USED WHEN THIS INCIDENT OCCURRED. NO FURTHER INVESTIGATION CAN BE COMPLETED WITH RETENTION MATERIAL. BD OFFERS A DEVICE CALLED "ROBOGRIPS" WHICH CUSTOMERS USE TO CRUSH THESE AMPULES. FURTHER CONVERSATION WITH THE CUSTOMER REVEALED THEY ARE AWARE OF THE PRODUCT, BUT NEVER THOUGHT THEY WERE NECESSARY BECAUSE THEY HAVE NEVER HAD A PROBLEM BEFORE. INFO REGARDING THE ROBOGRIPS HAS BEEN SENT TO THE CUSTOMER FOR FURTHER CONSIDERATION. TO BETTER EDUCATE CUSTOMERS REGARDING THE USE OF THIS PRODUCT, BD WILL BE REVISING THE PACKAGE INSERT TO ADD A PRECAUTION REGARDING THIS TYPE OF ISSUE AND INCLUDE A REFERENCE FOR USE OF THE ROBOGRIP PLIERS. BD WILL CONTINUE TO MONITOR THIS TYPE OF ISSUE.