Description of Event or Problem · 1
ALTHOUGH IT IS LESS THAN CLEAR THAT THIS IS A REPORTABLE EVENT BECAUSE NO PRODUCT WITH UNSEALED POUCHES, AS DESCRIBED BELOW HAS BEEN CONFIRMED TO HAVE BEEN DISTRIBUTED, AND NO ADVERSE EVENTS HAVE BEEN REPORTED, THE COMPANY IS ERRING ON THE SIDE OF CAUTION AND SUBMITTING THIS REPORT. DURING ROUTINE INTERNAL SURVEILLANCE, THREE PARAMOUNT STENT UNITS THAT WERE NEVER DISTRIBUTED WERE FOUND TO HAVE UNSEALED POUCHES. IF PRODUCTS IN UNSEALED POUCHES WERE DISTRIBUTED, THE PRODUCTS WOULD NOT BE STERILE. A THOROUGH INVESTIGATION, INCLUDING COMPLAINTS, EXAMINATION OF SEALING RECORDS FOR THE AFFECTED LOT AND EXAMINATION OF INVENTORY ON HAND, INDICATED THAT THE SEALING PROBLEM WAS ATTRIBUTABLE TO OPERATOR ERROR. AS A PRECAUTION, A SAFETY ALERT WAS ISSUED FOR ALL PRODUCT IN LOTS SEALED BY THE IDENTIFIED OPERATORS, INCLUDING INTRASTENT DOUBLESTRUT PARAMOUNT XS AND PROTEGE SELF-EXPANDING NITINOL STENTS. THE PROTEGE STENTS WERE INCLUDED TO BE THOROUGH EVEN THOUGH NO UNSEALED POUCHES FOR PROTEGE UNITS WERE DISCOVERED IN INVENTORY ON HAND. THE SAFETY ALERT REQUESTED QUARANTINE OF ALL THE IDENTIFIED PRODUCTS UNTIL A COMPANY REPRESENTATIVE EXAMINED AND CONFIRMED THE POUCH SEAL.