BARD® GOODWIN SOUND

Additional Manufacturer Narrative

THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF A QUITE FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. 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 THE POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF A QUITE FEW GOODWIN SOUND REPLACEMENTS AS IT HAD CONSISTENTLY ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. 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 THE POINT OF USE. THE BOX AND PACKAGING THAT CUSTOMER RECEIVED WAS FOR 11 SOUNDS. THEY HAVE TOTAL OF 24 SOUNDS.

Additional Manufacturer Narrative

THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE DID NOT FAIL TO MEET RELEVANT SPECIFICATIONS. AS THE PRODUCT WAS NOT USED ON A PATIENT IT WAS NOT USED FOR DIAGNOSTIC OR TREATMENT PURPOSES. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. THE DEVICE WAS RETURNED FOR EVALUATION. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. AS THE REPORTED EVENT IS UNCONFIRMED A RISK REVIEW AND LABELING REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.