Description of Event or Problem · 1
DURING AN EYE STRABISMUS SURGERY, A 6-0 VICRYL SUTURE WAS USED AND BEGAN TO FRAY IN SEVERAL AREAS ALONG THE SUTURE.A SECOND PROCEDURE WAS SCHEDULED SAME DAY WITH A NEW PATIENT. THE OR NURSE OBTAINED THE SAME 6-0 VICRYL SUTURES, BUT FROM A DIFFERENT LOT THAN THE FIRST FAILURE AND THE SAME FRAYING OCCURRED. THE PHYSICIAN DID CONTINUE TO USE THE FRAYED SUTURE ONCE STARTED IN BOTH OF THESE CASES.IN A THIRD CASE, SAME DAY, SAME PROCEDURE, THE 6-0 VICRYL SUTURE PACKAGE WAS OPENED FROM STERILE PACKAGING FOR USE. THE PHYSICIAN NOTED AT THAT TIME THE SUTURE WAS FRAYED. THIS SUTURE WAS NOT USED AND RETAINED. ALL REMAINING BOXES FROM BOTH LOTS HAVE BEEN REMOVED FROM OR STOCK TO BE RETURNED TO MANUFACTURER.MANUFACTURER RESPONSE FOR SUTURE, ABSORBABLE, COATED VICRYL, (PER SITE REPORTER): VENDOR REPRESENTATIVE CONTACTED BY MATERIALS MANAGEMENT. ALL UNOPENED BOXES FROM BOTH LOTS TO BE RETURNED AND REPLACED WITH NEW.MANUFACTURER RESPONSE FOR SUTURE, ABSORBABLE, COATED VICRYL, (PER SITE REPORTER): VENDOR REPRESENTATIVE CONTACTED BY MATERIALS MANAGEMENT. ALL UNOPENED BOXES FROM BOTH LOTS TO BE RETURNED AND REPLACED WITH NEW.MANUFACTURER RESPONSE FOR SUTURE, ABSORBABLE, COATED VICRYL, (PER SITE REPORTER): VENDOR REPRESENTATIVE CONTACTED BY MATERIALS MANAGEMENT. ALL UNOPENED BOXES FROM BOTH LOTS TO BE RETURNED AND REPLACED WITH NEW.