Additional Manufacturer Narrative · 1
IT WAS ONE OF 120 VALVES, JAMNER ARTICLE NO. RB2627 PRODUCED WITH LOT # 223M FROM JULY TO SEPT 2006. ALL WERE SOLD TO JARIT/JAMNER AS FOLLOWS: 7/31/2006; 8/2/2006; 9/29/2006; 10/5/2006. FROM ALMOST DEVICES SOLD TO THE USA SINCE 2006, THIS IS THE SIXTH INCIDENT IN APPROX SIX MONTHS ( DURING FOUR (4) PROCEDURES) THAT WAS CAUSED BY A COMPARABLE DEVICE FAILURE: THE FRACTURE OR BREAKING OFF THE STUD ( LOCATING BOLT) HOLDING THE VALVE. THE INTENSIVE INVESTIGATIONS FOLLOWING THE PREVIOUS EVENTS (SEE SUPPLEMENTAL REPORTS WITH DETAILED CAPA SUMMARY SUBMITTED 2/5/2008) RESULTED IN A PARTIAL REDESIGN, TI MATERIAL CHANGE, AND DIFFERENT WELDING TECHNIQUE. THESE CHANGES HAVE SINCE BEEN APPROVED BY THE CUSTOMER AND WILL AFFECT ALL NEW PRODUCTION OF THESE DEVICES. THE MFR, TOGETHER WITH THE DISTRIBUTOR, BELIEVE THAT THESE CHANGES SHOULD GREATLY MINIMIZE THE RISK FOR THE OCCURRENCE OF FUTURE EVENTS WITH THIS DEVICE.