POSIFLUSH- SP

Additional Manufacturer Narrative

TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES AND THE AFFECTED PHYSICAL SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH INITIAL INSPECTION, THE SALINE SOLUTION CONTAINED A BROWNISH PARTICLE. SIMULATION WAS PERFORMED TO SEE IF THE PARTICLE COULD BE EXPELLED FROM THE SYRINGE AND IT WAS ABLE TO BE EXPELLED. THE PARTICLE SIZE WAS 1.31 MM DIAMETER IN WET CONDITIONS, 0.90 MM IN DRY CONDITIONS, AND THE PARTICLE WAS MALLEABLE. FOURIER-TRANSFORM INFRARED (FTIR) SPECTROSCOPY WAS PERFORMED ON THE FOREIGN PARTICLE FOR IDENTIFICATION. THE FTIR RESULTS WERE FOUND TO BE CONCLUSIVE WITH RESULTS DETERMINING THE FOREIGN MATTER WAS BIOLOGICAL IN NATURE AND ONE OF THE TOP MATCHES WAS HUMAN SKIN. THE SAMPLE WAS TESTED FOR BLOOD USING A SIEMENS HEMASTIX TEST STRIP AND TESTED POSITIVE. IN CONCLUSION, THE FOREIGN MATTER WAS BLOOD AND THE PHYSICAL APPEARANCE OF THE SAMPLE APPEARED TO BE A CORE. BASED ON THE EVIDENCE, IT SEEMS THAT THE FOREIGN MATTER COULD HAVE ORIGINATED FROM THE PATIENT IF THERE WAS AN ATTEMPT OF ASPIRATION WHILE USING THE POSIFLUSH SYRINGE. THIS PRACTICE CAN DRAW BIOLOGICAL MATERIAL FROM THE CATHETER AND/OR CONNECTOR INTO THE SYRINGE. AS PER THE INVESTIGATION PERFORMED, THE FOREIGN MATTER DID NOT ORIGINATE IN THE MANUFACTURING PLANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575 AND LOT NUMBER 5044939. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT, AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. THE MANUFACTURING FACILITY HAS SEVERAL POINTS TO AVOID CONTAMINATION OF THE SOLUTION. IN THE FILLING AREA, BARRELS ARE AIR WASHED SO NO PARTICLES ARE LEFT INSIDE AND THE STOPPERS ARE WASHED PRIOR TO FILLING WITH SALINE SOLUTION. HIGH EFFICIENCY PARTICULATE AIR (HEPA) FILTERS ARE USED IN THE FILL ROOM AND THE SYRINGES ARE FILLED WITH A FILTERED SALINE SOLUTION. BARREL HANDLING AND SALINE FILLING ARE CONDUCTED THROUGH AN AUTOMATED PROCESS WITH NO HUMAN INPUT. AN AUTOMATED VISION SYSTEM INSPECTS ALL SYRINGES FOR PARTICULATES IN THE SOLUTION AFTER THE FILLING PROCESS. VISUAL INSPECTIONS ARE ALSO PERFORMED FROM THE FILLING PROCESS TO THE PACKAGING PROCESS. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

AN UNIDENTIFIED BROWN FOREIGN SUBSTANCE WAS FOUND INSIDE THE SYRINGE.