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 QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT CONSISTENTLY HAD ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. ALSO STATED THAT UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER NOTIFICATION FROM INVESTIGATOR ON (B)(6) 2022 BASED ON SAMPLE RETURNED, IT WAS REPORTED THAT THE DILATION CATHETERS WERE CORRODED.

Description of Event or Problem

IT WAS REPORTED THAT THE CUSTOMER RECEIVED A PARTIAL ORDER OF QUITE A FEW GOODWIN SOUND REPLACEMENTS AS IT CONSISTENTLY HAD ISSUES WITH RUST AND DISCOLORATION IN THE LUMEN. ALSO STATED THAT UPON RECEIVING THE NEW REPLACEMENTS, THEY WERE INSPECTED WITH A BORESCOPE AND DISCOLORATION WAS NOTED PRIOR TO ANY REPROCESSING. PER NOTIFICATION FROM INVESTIGATOR ON 04FEB2022 BASED ON SAMPLE RETURNED, THE ADDITIONAL RECORDS WERE CREATED BASED ON THE MATERIAL NUMBERS OF THE SAMPLES RECEIVED . THE RETURNED MATERIAL NUMBERS WERE (042814), (042816), (042820), (042824), (042826) AND (042828).

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 DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. THE ACTUAL/SUSPECTED DEVICE WAS EVALUATED.