Description of Event or Problem · 1
WHEN THE NURSE WAS EXAMINING THE SYRINGE AND NEEDLE PRIOR TO DRAWING UP INSULIN, SHE NOTICED THAT THE NEEDLE LOOKED "RUSTY". SHE DISCARDED THAT SYRINGE AND TOOK ANOTHER ONE TO USE FOR THE INSULIN ADMINISTRATION. SHE NOTED THE SAME ISSUE WITH THAT NEEDLE. PURCHASING DEPARTMENT WAS NOTIFIED ALONG WITH PT SAFETY AND THIS LOT WAS IMMEDIATELY REMOVED FROM THE FACILITY AND THE REP OF THE COMPANY NOTIFIED AND ANOTHER PRODUCT REPLACEMENT WAS SENT TO THE FACILITY. THE OCCURRENCE REPEATED WITH ANOTHER LOT ON (B)(6) 2013. AGAIN, THE REP WAS NOTIFIED AND THOSE SYRINGES REMOVED FROM SERVICE. I REQUESTED THAT THE QA REP FROM SMITHS CONTACT ME WITH RESOLUTION AND TO PROVIDE ME WITH A COPY OF THE MEDWATCH FORM THAT THE COMPANY SUBMITTED SINCE USE OF THIS PRODUCT COULD HAVE CAUSED A PT INJURY. THE EMAIL FROM (B)(4) WAS AS FOLLOWS: "WHILE SMITHS MEDICAL REPORTS ALL COMPLAINTS TO THE FDA THAT MEET OUR CRITERIA FOR REPORTING VIA MEDWATCH, THESE TWO COMPLAINTS WERE NOT FOUND TO MEET THAT CRITERIA." WE ARE SUBMITTING THIS MEDWATCH FORM REGARDING A POTENTIAL PT SAFETY ISSUE THAT WE WOULD LIKE ADDRESSED PRIOR TO IT BECOMING A TP SAFETY ISSUE. WE REPLACED THESE SYRINGES INITIALLY WITH CARDINAL SYRINGES, WHICH TURN OUT TO BE PRODUCED BY SMITHS MEDICAL, DIFFERENT LOT BUT ULTIMATELY THE SAME ISSUE. ALL SYRINGES INCLUDED IN THIS COMMUNICATION WERE RETURNED TO THE COMPANY REP FOR EXAMINATION. TWO PRODUCTS DISTRIBUTED UNDER SMITHS MEDICAL, THE SECOND MADE BY SMITHS FOR CARDINAL.