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Additional Manufacturer Narrative

A PHOTO WAS RECEIVED. THE PHOTO SHOWS THE EXTERIOR OF ONE OUTER CLAY BOARD BOX. IT APPEARS TO BE THE BACKSIDE OF THE BOX AND THERE IS OBSERVED DAMAGE. NO OTHER IDENTIFYING MARKS OR LABELS ARE VISIBLE. UNABLE TO VERIFY THAT THE BOX IS THE IMPACTED PRODUCT, OR IF THERE IS PRODUCT INSIDE THE BOX FROM THE PROVIDED PHOTOGRAPH. BASED ON THE IMAGE, A DAMAGED WHITE CLAYBOARD BOX IS CONFIRMED. HOWEVER, THE PHOTO IS INSUFFICIENT TO DETERMINE A POSSIBLE CAUSE FOR THE DAMAGE, IF THERE IS PRODUCT INSIDE THE WHITE BOX OR IF A PRIMARY PACKAGE IS DAMAGED. WHILE IT IS REPORTED THAT THE CONDITION IS DUE TO WEATHER/RAIN CONDITIONS, THERE IS NO ADDITIONAL EVIDENCE TO ASCERTAIN WHEN THIS DAMAGE WAS CAUSED OR IF DURING DELIVERY, HANDLING OR STORAGE OF THE PRODUCT. STERILITY INTEGRITY COMPROMISED CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR LOT 2241215 WAS REVIEWED AND THERE WERE NO IDENTIFIED MANUFACTURING DEFICIENCIES OR INTERNAL ACTIONS. ALL FINISHED GOODS DEVICES HAD PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO DISTRIBUTION. NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. ONCE THE PRODUCT OR ADDITIONAL INFORMATION IS RECEIVED, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY STERILMED INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, STERILMED INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REF. (B)(4).

Description of Event or Problem

:IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETER AND THE STERILITY WAS COMPROMISED. THE INNER WHITE BOX WAS DAMAGED DUE TO WEATHER/RAIN CONDITIONS. IN ADDITION, THERE WAS DAMAGE TO THE POUCH. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.