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Additional Manufacturer Narrative

IT WAS REPORTED THAT THE BOX OF THE REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED WITH EXTENSIVE WATER DAMAGE. FOUR (4) PHOTOS ACCOMPANIED THE COMPLAINT FILE. THIS INVESTIGATION CAPTURES THE ANALYSIS OF THE RETURNED, NON-STERILE REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND 8FR FOR USE WITH SIEMENS SYSTEM, (B)(4), WHICH WAS RECEIVED INSIDE OF ITS PRIMARY PACKAGE. NONE OF THE OUTER PACKAGING MATERIALS (THE WHITE CLAYBOARD BOX OR THE SHIPPING CONTAINER) WERE RETURNED FOR ANALYSIS. ALSO OF NOTE, THIS RECEIVED DEVICE & PACKAGE WERE NOT CAPTURED IN ANY OF THE RETURNED PHOTOGRAPHS. THE PHOTOGRAPHS PROVIDED ARE INSUFFICIENT TO CONFIRM THE REPORTED ISSUE OR ASSESS A POSSIBLE CAUSE FOR THIS RETURNED DEVICE. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS CONDUCTED. THE DEVICE AND PACKAGE WERE RETURNED FOLDED IN HALF INSIDE THE RETURN CONTAINER, NOT THE SAME CONTAINER AS THE DEVICE WAS ORIGINALLY SHIPPED INSIDE TO THE CUSTOMER. THE DEVICE IS OBSERVED TO BE BENT AT THE STRAIN RELIEF, AND THE SHAFT OF THE DEVICE IS STILL INSIDE THE PROTECTIVE TUBE. THIS OBSERVED BEND AT THE STRAIN RELIEF WAS NOT ORIGINALLY REPORTED AND IT WAS UNDETERMINED IF IT IS DUE TO THE WAY THE MATERIAL WAS RETURNED OR THE EXACT TIME OF THE OCCURRENCE AND IS ASSESSED TO BE UNRELATED TO THE REPORTED ISSUE. THE TUBING IS NOTED TO BE CURVED. THE TYVEK MATERIAL AND CLEAR PLASTIC PARTS OF THE PACKAGE ARE WRINKLED AND FOLDED IN VARIOUS SPOTS, BUT THERE IS NO BREACH. THE OBSERVED, RETURNED CONDITION OF THE PACKAGE CONFIRMS IT IS DAMAGED. HOWEVER, IT IS UNDETERMINED IF IT IS DUE TO THE WAY THE MATERIAL WAS RETURNED, RELATED TO THE REPORTED ISSUE OR THE EXACT TIME OF THE OCCURRENCE. THERE IS ALSO NO INDICATION OR OBSERVATION THAT PACKAGE STERILITY IS COMPROMISED OR HAS INDICATIONS OF MOISTURE PREVIOUSLY INSIDE THE VALIDATED ETHYLENE OXIDE PERMEABLE PACKAGE. ADDITIONALLY, THERE ARE NO OBSERVED, REMAINING WATER STAINS OR DROPLETS ON OR IN THE PACKAGE. THE PHYSICAL MARK ON THE DEVICE, SERIAL NUMBER (B)(6), INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME UNDER LOT 2236888. THE ISSUE REGARDING THE STERILITY IS NOT CONFIRMED BASED ON THE OBSERVED CONDITION OF THE RETURNED PRODUCT. HOWEVER, THE CAUSE OF THE REPORTED ISSUE, OR WHEN IT OCCURRED (DURING TRANSIT DELIVERY, AS WELL AS REMOVAL AND SUBSEQUENT HANDLING FROM ITS PACKAGING) IS UNDETERMINED. THE DEVICE HISTORY RECORD FOR LOT 2236888 WAS REVIEWED AND THERE WERE NO IDENTIFIED MANUFACTURING DEFICIENCIES OR INTERNAL ACTIONS SINCE THE IMPACTED PRODUCT HAD PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO DISTRIBUTION. AS PART OF STERILMED' S QUALITY PROCESS, ALL THE DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EACH DEVICE UNDERGOES 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT ANY DAMAGE FROM LEAVING THE FACILITY. THERE IS NO EVIDENCE TO SUGGEST THE EVENT IS RELATED TO A MANUFACTURING OR DESIGN ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. ADDITIONAL DETAILS FOR INITIAL REPORTER E UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

Additional Manufacturer Narrative

THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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. NO: (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT THE BOX OF THE REPROCESSED ACUNAV DIAGNOSTIC ULTRASOUND CATHETER WAS RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND THE WHITE PRODUCT BOX INSIDE THE SHIPPING BOX WAS WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOX, WATER DROPLETS WERE OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOX WAS VISIBLY DISCOLORED FROM THE WATER/LIQUID.