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Additional Manufacturer Narrative

IT WAS REPORTED THAT SEVERAL BOXES OF REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WITH EXTENSIVE WATER DAMAGE. FOUR (4) PHOTOS WERE RECEIVED FOR THE EVENT. THE FIRST PHOTO SHOWS THE LABEL AND THE PACKAGE OPENED, REVEALING THE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM. INSIDE THE POUCH, A PORTION OF THE HANDLE WITH THE CONNECTOR, THE STRAIN RELIEF AND THE SERIAL NUMBER TAG CAN BE SEEN. THE DEVICE WAS OBSERVED TO BE FOGGED UP AND WETNESS ON THE SIDE WHERE THE ECO CONNECTOR IS LOCATED. THE SECOND PHOTO PROVIDES A CLOSER VIEW OF THE PART OF THE DEVICE WHERE THE SWIFT LINK AND ECO CONNECTOR ARE LOCATED, SHOWING MOISTURE INSIDE THE POUCH. THE THIRD PHOTO SHOWS THE HANDLE OF THE DEVICE WITH MOISTURE. THE FOURTH PHOTO SHOWS DEVICE, FROM THE CONNECTOR TO THE TAG END, DISPLAYING TRACES OF MOISTURE AND EVEN WATER DROPLETS. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETER FOR USE ON SIEMENS IMAGING SYSTEM WAS RECEIVED INSIDE OF THE INNER POUCH. UPON RECEIVING THE DEVICE, A VISUAL INSPECTION WAS PERFORMED, AND THE DEVICE WAS FOUND INSIDE THE INNER POUCH, WHICH WAS SLIGHTLY OPEN AT ONE END, POTENTIALLY COMPROMISING THE STERILITY OF THE PRODUCT, EVEN THOUGH THE SEAL APPEARED TO REMAIN INTACT. THE SHAFT OF THE DEVICE WAS STILL INSIDE THE PROTECTIVE TUBE AND WAS FOUND TO BE CURVED AT THE STRAIN RELIEF; HOWEVER, IT DID NOT SHOW ANY SIGNS OF DAMAGE WITH THE PLASTIC OF THE POUCH. ADDITIONALLY, WATER STAINS WERE OBSERVED IN THE UPPER MIDDLE PART OF THE TYVEK. THE PHYSICAL MARK ON THE DEVICE INDICATED THAT IT HAD BEEN REPROCESSED ONE (1) TIME. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REGARDING THE WET CONDITION ON THE PACKAGE WAS CONFIRMED. WITH THE LIMITED INFORMATION AVAILABLE, THE ENVIRONMENTAL CONDITIONS OF THE HANDLING AND STORAGE OF THE DEVICE CANNOT BE DETERMINED; HOWEVER, THE CAUSE OF THE ISSUE OR WHEN IT OCCURRED (DURING TRANSIT DELIVERY, AS WELL AS REMOVAL AND SUBSEQUENT HANDLING FROM ITS PACKAGING) IS UNDETERMINED, AND NO FURTHER EVALUATION CAN BE PERFORMED SINCE THE OUTER PACKAGE WAS NOT RETURNED FOR EVALUATION. THE CURVED CONDITION WAS NOT ORIGINALLY REPORTED, AND THE EXACT TIME OF OCCURRENCE CANNOT BE DETERMINED; THEREFORE, THIS IS NOT CONSIDERED RELATED TO THE ISSUE REPORTED. AS PART OF STERILMED' S QUALITY PROCESS, ALL THE DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EACH DEVICE (FROM ITS PROXIMAL HANDLE AND CONNECTOR TO THE DISTAL TIP) UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT ANY DAMAGE FORM LEAVING THE FACILITY. 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).

Description of Event or Problem

IT WAS REPORTED THAT SEVERAL BOXES OF REPROCESSED SOUNDSTAR ECO 8F DIAGNOSTIC ULTRASOUND CATHETERS WERE RECEIVED WITH EXTENSIVE WATER DAMAGE. THE OUTER SHIPPING BOX WAS WET AND SOME OF THE WHITE PRODUCT BOXES INSIDE THE SHIPPING BOXES WERE WET AS WELL. UPON INSPECTION OF THE PRODUCT INSIDE THE WET WHITE BOXES, SEVERAL HAD WATER DROPLETS OUTSIDE AND INSIDE THE STERILE PACKAGING. THE WHITE BOXES WERE VISIBLY DISCOLORED FROM THE WATER/LIQUID.

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. 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).