BARD® GOODWIN SOUND

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED HOWEVER THE CAUSE WAS UNKNOWN. ONE SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. AS THE DEVICE WAS NOT USED ON A PATIENT IT WAS NOT USED FOR DIAGNOSTIC OR TREATMENT PURPOSES. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "IMPROPER HIGH LEVEL DISINFECTION OR STERILIZATION". A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "IMPROPER HIGH LEVEL DISINFECTION OR STERILIZATION". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "VISUAL INSPECTION EXAMINE EACH DEVICE FOR CLEANLINESS. IF VISIBLE SOIL REMAINS, REPEAT MANUAL CLEANING INSTRUCTIONS. VERIFY THAT DEVICES ARE FREE OF DEFORMATIONS (E.G. BENT, BROKEN, CORRODED, CRACKED, WORN, OR FRACTURED) THAT MAY IMPACT ITS INTENDED USE. DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DEFECTIVE."

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY HAD ISSUES WITH RUST 042822 AND 042820 AND DISCOLORATION 042816AND 042814 IN THE LUMEN. IT WAS ALSO STATED UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER FOLLOW UP VIA EMAIL ON 16AUG21, THE LOT NUMBERS OF THE AFFECTED SOUNDS WHICH ARE MIXED WITH NEW BOX AND NEVER PROCESSED. THE NEW BOX, WHICH WAS PROCESSED INITIALLY, NEVER USED ON PATIENT. THIS WAS THE ONGOING ISSUE FOR THE CUSTOMER AND CONSISTENTLY REPLACING THESE. THE CUSTOMER CHECKED AND VERIFIED INTERNAL PROCESS AND FOLLOW THE IFU VERBATIM, FLUSHING WITH STERILE WATER AT POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS 042824 AND 042826.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS CONFIRMED HOWEVER THE CAUSE WAS UNKNOWN. ONE SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. AS THE DEVICE WAS NOT USED ON A PATIENT IT WAS NOT USED FOR DIAGNOSTIC OR TREATMENT PURPOSES. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "IMPROPER HIGH LEVEL DISINFECTION OR STERILIZATION". A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "IMPROPER HIGH LEVEL DISINFECTION OR STERILIZATION". THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "VISUAL INSPECTION EXAMINE EACH DEVICE FOR CLEANLINESS. IF VISIBLE SOIL REMAINS, REPEAT MANUAL CLEANING INSTRUCTIONS. VERIFY THAT DEVICES ARE FREE OF DEFORMATIONS (E.G. BENT, BROKEN, CORRODED, CRACKED, WORN, OR FRACTURED) THAT MAY IMPACT ITS INTENDED USE. DO NOT USE THE PRODUCT IF IT IS DAMAGED OR DEFECTIVE."

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY HAD ISSUES WITH RUST 042822 AND 042820 AND DISCOLORATION 042816AND 042814 IN THE LUMEN. IT WAS ALSO STATED UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER FOLLOW UP VIA EMAIL ON 16AUG21, THE LOT NUMBERS OF THE AFFECTED SOUNDS WHICH ARE MIXED WITH NEW BOX AND NEVER PROCESSED. THE NEW BOX, WHICH WAS PROCESSED INITIALLY, NEVER USED ON PATIENT. THIS WAS THE ONGOING ISSUE FOR THE CUSTOMER AND CONSISTENTLY REPLACING THESE. THE CUSTOMER CHECKED AND VERIFIED INTERNAL PROCESS AND FOLLOW THE IFU VERBATIM, FLUSHING WITH STERILE WATER AT POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS 042824 AND 042826.