Description of Event or Problem · 1
FOREIGN PARTICLE, WHICH LOOKED LIKE "HAIR", DISCOVERED WITHIN MEDRAD CT SYRINGE ITSELF. THIS SYRINGE IS SUPPLIED SEPARATELY IN A STERILE PACKAGE. MATERIAL COULD BE A HAIR OR POSSIBLY FINELY SEPARATED RUBBER MATERIAL FROM THE BLACK PLUNGER OF THE SYRINGE. ALL CT, MR AND INTERVENTIONAL RADIOLOGY DEPARTMENTS THAT USE MEDRAD SYRINGES HAVE BEEN NOTIFIED TO: (1) TO PULL LOT NUMBERS, (2) INSPECT EACH SYRINGE PRIOR TO USE AND (3) POST SIGN AT EACH INJECTOR. IN ADDITION, AT ONE FACILITY, EPIDEMIOLOGY, INFECTION CONTROL, LEGAL AND PATIENT SAFETY AND QUALITY DEPARTMENTS HAVE BEEN NOTIFIED. MEDRAD, INC. WAS CONTACTED, AND THE PROBLEM WAS REPORTED TO THEM. A MEETING WAS ARRANGED WITH MEDRAD, AND AN ACTION PLAN HAS BEEN FORMED AND SUBMITTED: (1) MEDRAD WILL TAKE SYRINGES FOR FAILURE ANALYSIS, (2) WITHIN TWO WEEKS, AN UPDATE WILL BE GIVEN BY MEDRAD TO COMMUNICATE PRELIMINARY FINDINGS, (3) INFORMATION PERTAINING TO THIS INCIDENT WILL BE COMMUNICATED TO MEDRAD'S VENDORS AND SUPPLIERS WHO MANUFACTURE THE COMPONENTS OF THE SYRINGES TO IMPROVE QUALITY CONTROL, (4) MANUFACTURER WILL PROVIDE CREDIT FOR THE SYRINGES, (5) ADDITIONAL TRAINING WILL BE GIVEN TO MEDRAD AND VENDOR STAFF TO REDUCE THE POSSIBILITY OF THIS OCCURRING IN THE FUTURE. IN ADDITION, REPRESENTATIVES FROM MEDRAD ASSURED US THAT THEY ARE DOING EVERYTHING POSSIBLE TO CORRECT THIS SPIKE IN SYRINGE CONTAMINATION. ONE STATISTIC THEY PROVIDED WAS THAT 50,000,000 SYRINGES WERE MANUFACTURED OVER THE LAST 3 YEARS AND ONLY SIX REPORTED COMPLAINTS OF HAIR IN A SYRINGE HAVE BEEN RECEIVED. OF THE SIX FAILURES, THREE SEPARATE INCIDENTS OCCURRED WITHIN THE SPAN OF A WEEK AT OUR FACILITY.