NA

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).

Description of Event or Problem

IT WAS REPORTED THAT THE PACKAGE OF A REPROCESSED SOUNDSTAR CATHETER WAS WET, AND THE BACK SIDE PAPER OF THE DEVICE PACKAGING WAS WET, WHICH AFFECTED THE POUCH AND COMPROMISING THE STERILITY. THE SHIPPING BOX ARRIVED AT THE DEPARTMENT DAMP, WHICH CAUSED FOR THE TOP LEFT SIDE OF THE BOX TO BE CRUMPLED. SUPPLIES ARE NOT ALWAYS RECEIVED THE SAME DAY, SO IT IS UNKNOWN IF THAT WAS HOW IT ARRIVED AT THE HOSPITAL AT THE RECEIVING DOCK. THERE WERE NO OTHER BOXES THAT WERE WET THAT DAY OR THE PREVIOUS DAY. THERE WAS NO PATIENT INJURY OR CONSEQUENCE.

Additional Manufacturer Narrative

IT WAS REPORTED THAT THE PACKAGE OF A REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON SIEMENS IMAGING SYSTEM (BIO10438577/2207142) WAS WET, AND THE BACK SIDE PAPER OF THE DEVICE PACKAGING WAS WET, WHICH AFFECTED THE POUCH AND COMPROMISING THE STERILITY. THE DEVICE WAS RETURNED TO STERILMED FOR FURTHER EVALUATION. A NON-STERILE REPROCESSED CATHETER SOUNDSTAR ECO 3D DIAGNOSTIC ULTRASOUND FOR USE ON SIEMENS IMAGING SYSTEM WAS RECEIVED CONTAINED IN THE DECONTAMINATION BAG. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND THE DEVICE WAS RETURNED INSIDE THE INNER POUCH AND INSIDE THE OUTER PACKAGING. THE TOP LEFT SIDE OF THE OUTER PACKAGING WAS DAMAGED, AND WATER STAINS WERE NOTED ON THE TOP LEFT SIDE OF THE TYVEK POUCH. THE STERILITY SEAL OF THE TYVEK POUCH REMAINED INTACT; HOWEVER, THE WATER STAINS WERE VISIBLE FROM THE INNER POUCH. THE PHYSICAL MARK ON THE DEVICE INDICATED IT HAD BEEN REPROCESSED ONE (1) TIME. A DEVICE HISTORY RECORD (DHR) WAS PERFORMED, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE PACKAGING OF THE REPROCESSED CATHETER BEING WET WAS CONFIRMED. WITH THE LIMITED INFORMATION AVAILABLE, THE ENVIRONMENTAL CONDITIONS OF THE HANDLING AND STORAGE OF THE DEVICE CANNOT BE DETERMINED; HOWEVER, UNSUITABLE CONDITIONS CAN POTENTIALLY COMPROMISE THE CATHETER'S INTEGRITY. THERE IS NO INDICATION THAT THE ISSUE REPORTED IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE DEVICE. AS PART OF STERILMED'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. DEVICES UNDERGO 100% INSPECTION AT DIFFERENT POINTS DURING THE MANUFACTURING PROCESS TO PREVENT DAMAGES FROM LEAVING THE FACILITY. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).