NA

Additional Manufacturer Narrative

THE LOT AND SERIAL NUMBER OF THE DEVICE WERE OBTAINED. SECTIONS D4. LOT AND D4. SERIAL HAVE BEEN 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

IT WAS REPORTED THAT A REPROCESSED ACUSON ACUNAV¿ ULTRASOUND CATHETER WAS RECEIVED DAMAGED THROUGH SHIPPING. THE EXTERIOR, INTERIOR AND INTERNAL STERILE PACKAGING OF THE CATHETER AND BOX WERE ALL DAMAGED WHEN RECEIVED. FOUR (4) IMAGES WERE PROVIDED ALLEGEDLY SHOWING THE SAME PRODUCT AND SHIPPING CONTAINER. THE RESOLUTION OF THE IMAGES IS INSUFFICIENT TO VERIFY THE LOT NUMBER, SERIAL NUMBER, SHIPPING ORDER OR TRACKING NUMBER. IN TWO OF THE IMAGES PROVIDED, IT CAN BE OBSERVED THAT THE CATHETER¿S OUTER CARTON BOX AND SHIPPING CONTAINER APPEAR DAMAGED. IN THE OTHER TWO IMAGES, THE PROTECTIVE TUBING APPEARS TO BE BENT AND A PORTION OF THE PACKAGE, AROUND THE STRAIN RELIEF, WITH THE SERIAL NUMBER LABEL, SHOWS WHAT APPEARS TO BE A TEAR IN THE TYVEK SIDE OF THE PRIMARY PACKAGE, AS WELL AS DAMAGE OF THE DEVICE¿S SHAFT. THE RESOLUTION AND ANGLE OF THE PHOTO IS INSUFFICIENT TO VERIFY THE SERIAL NUMBER OF THE DEVICE. THE REPORTED ISSUE OF DAMAGED PACKAGING AND A BREACH OF THE CLEAR PLASTIC MATERIAL OF THE PRIMARY PACKAGE IS CONFIRMED BASED ON THE PHOTOS RECEIVED. THOUGH PRODUCT DAMAGE WAS IDENTIFIED, POSSIBLE CAUSE OF THE CURRENT APPEARANCE AS SEEN IN THE IMAGES COULD BE RELATED TO THE DELIVERY OF THE MATERIALS, THE HANDLING AND STORAGE OF THE PRODUCT UPON ITS RECEIPT AND DOES NOT APPEAR RELATED TO THE MANUFACTURING AND PACKAGING OF THIS PRODUCT. A MANUFACTURING RECORD EVALUATION WAS CONDUCTED FOR LOT NUMBER 2244307 AND THERE WERE NO IDENTIFIED INTERNAL ACTIONS. THERE IS NO EVIDENCE TO SUPPORT THE REPORTED EVENT AS BEING RELATED TO A REPROCESSING ISSUE. A NON-STERILE REPROCESSED ACUSON ACUNAV¿ ULTRASOUND CATHETER (NOT FOR USE ON SIEMENS SYSTEMS) 10F ULTRASOUND CATHETER, 10043342, WAS RECEIVED CONTAINED IN A DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS CONDUCTED AND IT IS NOTED THAT THE CATHETER WAS RETURNED WITH FOUR OBSERVED KINKS IN THE SHAFT ONE NEAR THE BASE OF THE STRAIN RELIEF AT THE PROXIMAL END OF THE SHAFT (WHERE THE SERIAL NUMBER LABEL IS ATTACHED), ONE APPROXIMATELY 3.5CM FROM THE PROXIMAL END, ANOTHER ONE APPROXIMATELY 33CM FROM THE PROXIMAL END AND ANOTHER AT 37CM FROM THE DISTAL TIP, WITH NO EXPOSED WIRES. THE PRODUCT HAD BEEN REMOVED FROM ITS PRIMARY PACKAGE. IT IS UNDETERMINED HOW THESE KINKS WERE CREATED. THE PRIMARY PACKAGE AND LABEL WERE RETURNED, FOLDED, ALONG WITH THE DEVICE. THERE IS AN OBSERVED PERFORATION ON THE CLEAR PLASTIC SIDE OF THE PACKAGE, APPROXIMATELY 45CM FROM THE CHEVRON OPENING. IT IS UNDETERMINED HOW THIS OPENING OCCURRED. THE SHIPPING CONTAINER, THE OUTER CLAYBOARD BOX PACKAGE NOR ANY OTHER PACKAGING MATERIALS SUCH AS THE PROTECTIVE TUBING AND BACKING BOARD, WERE NOT RETURNED FOR EVALUATION. THE DEVICE, SERIAL NUMBER (B)(6), HAD BEEN REPROCESSED TWO (2) TIMES, MOST RECENTLY UNDER LOT 2244307. THE REPORTED DAMAGE IS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD FOR LOT 2244307 WAS CONDUCTED AND THERE WERE NO IDENTIFIED MANUFACTURING OR PACKAGING DEFICIENCIES. THE IMPACTED PRODUCT HAD PASSED ALL VISUAL AND FUNCTIONAL CRITERIA PRIOR TO DISTRIBUTION. THE IMPACTED DEVICE WAS ONE OF SEVEN DEVICES SHIPPED TO THE ACCOUNT ON ORDER (B)(4). THERE IS NO REPORT OF DAMAGE EXPERIENCED ON ANY OF THE OTHER DEVICES ON THE SAME ORDER. WHILE IT IS ALSO REPORTED THAT THE SHIPPING CONTAINER HAD BEEN OBSERVED TO BE DAMAGED, AS WELL AS INTERNAL PACKAGING MATERIALS (I.E. THE HARD PROTECTIVE TUBING), THIS COULD NOT BE CONFIRMED AS THESE MATERIALS WERE NOT RETURNED. THERE IS NO INDICATION THAT THE ISSUE REPORTED IN THE COMPLAINT IS A RESULT OF A DEFECT INHERENTLY RELATED TO THE MANUFACTURING OF THE DEVICE. THE DAMAGE IS POSSIBLY RELATED TO IN-TRANSIT SHIPPING, AS WELL AS THE STORAGE AND/OR HANDLING OF THE DEVICE AFTER ITS DISTRIBUTION. 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 PHYSICAL DAMAGE ON THE DEVICES FROM LEAVING THE FACILITY. THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE. D4. EXPIRATION DATE, D4. PRIMARY UDI NUMBER, H4. DEVICE MANUFACTURE DATE AND H6. MEDICAL DEVICE PROBLEM CODE FIELDS WERE UPDATED. THE H6. MEDICAL DEVICE PROBLEM CODE IS BEING ADDED TO THE CODES ALREADY REPORTED. 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

CORRECTION TO SUPPLEMENTAL 1 AS DEVICE RETURN DETAILS WERE MISSED. THE PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. FOUR (4) IMAGES WERE PROVIDED ALLEGEDLY SHOWING THE SAME PRODUCT AND SHIPPING CONTAINER. NO LOT NUMBER WAS PROVIDED, AND THE RESOLUTION OF THE IMAGES ARE INSUFFICIENT TO ATTAIN THE LOT NUMBER, SERIAL NUMBER, SHIPPING ORDER OR TRACKING NUMBER. IN TWO OF THE IMAGES PROVIDED, IT CAN BE OBSERVED THAT THE CATHETER¿S OUTER CARTON BOX AND SHIPPING CONTAINER APPEAR DAMAGED. IN THE OTHER TWO IMAGES, THE PROTECTIVE TUBING APPEARS TO BE BENT AND A PORTION OF THE PACKAGE, AROUND THE STRAIN RELIEF, WITH THE SERIAL NUMBER LABEL, SHOWS WHAT APPEARS TO BE A TEAR IN THE TYVEK SIDE OF THE PRIMARY PACKAGE, AS WELL AS DAMAGE OF THE DEVICE¿S SHAFT. THE RESOLUTION AND ANGLE OF THE PHOTO IS INSUFFICIENT TO DETERMINE THE SERIAL NUMBER OF THE DEVICE. THE REPORTED ISSUE OF DAMAGED PACKAGING AND A BREACH OF THE CLEAR PLASTIC MATERIAL OF THE PRIMARY PACKAGE IS CONFIRMED BASED ON THE PHOTOS RECEIVED. THE DEVICE, PACKAGING AND LABELING HAVE NOT BEEN RETURNED FOR ANALYSIS. THOUGH PRODUCT DAMAGE WAS IDENTIFIED, POSSIBLE CAUSE OF THE CURRENT APPEARANCE AS SEEN IN THE IMAGES COULD BE RELATED TO THE DELIVERY OF THE MATERIALS, THE HANDLING AND STORAGE OF THE PRODUCT UPON ITS RECEIPT AND DOES NOT APPEAR RELATED TO THE MANUFACTURING AND PACKAGING OF THIS PRODUCT. A MANUFACTURING RECORD EVALUATION COULD NOT BE CONDUCTED AS THE LOT NUMBER, OR ANY ADDITIONAL IDENTIFYING INFORMATION, WAS NOT PROVIDED. THERE IS NO EVIDENCE TO SUPPORT THE REPORTED EVENT AS BEING RELATED TO A REPROCESSING ISSUE. ONCE THE PRODUCT IS RECEIVED, A COMPETE EVALUATION WILL BE CONDUCTED. 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 A REPROCESSED ACUSON ACUNAV¿ ULTRASOUND CATHETER WAS RECEIVED DAMAGED THROUGH SHIPPING. THE EXTERIOR, INTERIOR AND INTERNAL STERILE PACKAGING OF THE CATHETER AND BOX WERE ALL DAMAGED WHEN RECEIVED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION ON THIS COMPLAINT. HOWEVER, IT HAS NOT BEEN MADE AVAILABLE.