BD PROBETEC ET CT/GC AMPLIFIED DNA ASSAY COL

Description of Event or Problem

CUSTOMER CALLED TO REPORT THAT A CAP ON THE DILUENT TUBE USED TO PROCESS CLINICAL SPECIMENS LOOKS LIKE ITS ABOUT TO BLOW. CUSTOMER HAD EXPERIENCED AN ISSUE PREVIOUSLY IN WHICH A CAP ACTUALLY POPPED OFF A SAMPLE TUBE AFTER THE SAMPLE WAS LYSED AND AN INJURY OCCURRED (SEE MFR REPORT# 1119779-2009-00003). IN THIS INSTANCE, THE SAMPLE HAD A SIMILAR APPEARANCE, BUBBLING AROUND THE EDGE OF THE CAP. SHE CAREFULLY REMOVED IT FROM THE LYSE HEATER AND PROCESSED IT. NO INJURIES OCCURRED.

Additional Manufacturer Narrative

THIS PRODUCT IS PACKAGED AS A COLLECTION SET. THE SET INCLUDES A CLEANING SWAB, A COLLECTION SWAB AND A SAMPLE DILUENT VIAL. THE SAMPLE VIAL IS SENT TO LAB TO BE PROCESSED AND IS HEATED TO 112-116 DEGREES CELSIUS IN THE LYSING HEATER. ONCE THE SAMPLES ARE ALLOWED TO COOL FOR A PERIOD OF TIME, THE SAMPLE SWAB IS REMOVED FROM THE DILUENT AND THE DILUENT VIAL IS FURTHER PROCESSED. THE CUSTOMER COULD NOT SUPPLY THE LOT NUMBER OF THE VIAL THAT WAS INVOLVED IN THE INCIDENT. THE CUSTOMER HAD SAVED THE SAMPLE FOR THE DAY SHIFT TO RETURN TO BD FOR FURTHER INVESTIGATION BUT THE DAY SHIFT IS UNABLE TO LOCATE THE SAMPLE. BD IS UNABLE TO FURTHER INVESTIGATE A SPECIFIC LOT NUMBER. WHILE NO INJURY OCCURRED, THERE IS A CHANCE THAT IF THE ISSUE WERE TO RECUR WHERE THE CAP ACTUALLY POPS OFF, AN INJURY COULD OCCUR. ALTHOUGH BD WAS UNABLE TO CONFIRM THE ISSUE, WE WILL CONTINUE TO TREND AND INVESTIGATE THIS TYPE OF DEFECT.