APTIMA VAGINAL SPECIMEN COLLECTION KIT

Additional Manufacturer Narrative

THE DEVICE IN QUESTION WAS NOT AVAILABLE FOR EVAL.

Description of Event or Problem

ON MAY 17, 2010, GEN-PROBE SALES STAFF REC'D SECOND HAND INFO FROM AN EMPLOYEE OF A PUBLIC HEALTH CLINIC THAT THERE WAS AN INCIDENT AT ANOTHER INSTITUTION IN WHICH A VAGINAL SWAB BROKE WHILE THE PT WAS COLLECTING A SPECIMEN. GEN-PROBE WAS ABLE TO TRACK BACK TO DR (B)(6) WHO CONFIRMED THIS INFO AND STATED THAT A NURSE PRACTITIONER REMOVED THE SWAB FROM THE PT. SHE BELIEVED THE PT HAD HELD THE SHAFT AT A POINT CLOSER TO THE END AWAY FROM THE SWAB HEAD ALTHOUGH STEP 3 OF PRODUCT INSTRUCTION FOR THE COLLECTION KIT STATES: "HOLD THE SWAB IN YOUR HAND AS SHOWN IN DIAGRAM 2, PLACING YOUR THUMB AND FOREFINGER IN THE MIDDLE OF THE SWAB SHAFT." DR (B)(6) RECALLED THAT THE SWAB WAS LODGED AND PAINFUL FOR THE PT. PER DR (B)(6), THE INCIDENT OCCURRED BETWEEN (B)(6) 2009, BUT SHE COULD NOT PROVIDE THE SPECIFIC DATE OF INCIDENT OR NAME OF THE PT. DR (B)(6) ALSO INDICATED THAT A SIMILAR INCIDENT HAD HAPPENED SEVERAL TIMES IN THE PAST BUT ONLY THIS SPECIFIC INCIDENT REQUIRED THE SWAB SHAFT TO BE RETRIEVED FROM THE VAGINA USING A SPECULUM. NONE OF THESE INCIDENTS WERE REPORTED TO GEN-PROBE OR FILED VIA FDA FORM 3500A AT THE TIME WHEN THEY HAPPENED SO SPECIFIC LOT# AND PT INFO ARE NOT AVAILABLE.