NI

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER PHONE NO.: THE DEVICES WERE DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF UNKNOWN ELASTOMERIC DEVICES WERE FOUND WITH THE BLUE WINGED CAPS NOT FULLY SECURED. SEVERAL CAPS WERE OBSERVED TO BE INCOMPLETELY SCREWED ON WHEN THE DEVICES WERE REMOVED FROM THEIR PACKAGING. THERE WERE NO REPORTS OF PATIENT INJURY OR THE NEED FOR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.