DISPOSABLE MIXING BOWLS WITH SPATULA

Description of Event or Problem

IT WAS REPORTED THAT A FOREIGN MATERIAL GOT MIXED WITHIN THE PACKAGING OF THE SPATULA. ADDITIONAL INFO OBTAINED INDICATED THAT THE REPORTED CONTAMINATED PRODUCT ENTERED THE STERILE FIELD. THE CUSTOMER USED AND FINISHED THE SURGERY WITH AN ALTERNATIVE ONE. THERE WAS NO PATIENT HARM OR DELAYS REPORTED.

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED ON 05/20/2015 IN A PLASTIC ZIP LOCK BAG. THE SPATULA AND POUCH AND THE MIXING BOWL WERE RETURNED. THE CONTAMINATION WAS CAPTURED AND SAVED ON TWO STICKY TABS AND WAS INSIDE THE SPATULA POUCH. NO OBVIOUS DAMAGE WAS VISIBLE WITH THE RETURNED PRODUCT. THE EVALUATION OF THE CONTAMINATION THAT WAS RETURNED WITH THE DEVICE APPEARS TO BE PLASTIC - MOST PROBABLY FLASHING FROM THE SPATULA. THIS EVALUATION WAS ACCOMPLISHED USING A DIGITAL ELECTRONIC MICROSCOPE. THE CUSTOMERS REPORTED EVENT WAS FOREIGN MATERIAL WAS FOUND INSIDE THE POUCH OF THE SPATULA. THE INFORMATION PROVIDED AND THE RETURNED PRODUCT CONFIRM THAT CONTAMINANT WAS FOUND BY THE CUSTOMER. THE REVIEW OF THE DEVICE HISTORY RECORD (DHR) NOTED NO NON-CONFORMANCES. REQUESTS FOR DEVIATION (RPD'S) OR OTHER ISSUES. THE QUALITY RECORDS SHOW THAT THIS LOT WAS PREPARED IN ACCORDANCE WITH THE REQUIREMENTS OF THE QUALITY MANAGEMENT SYSTEM AND ALL THE QUALITY CONTROL TESTS WERE PASSED SUCCESSFULLY. ADDITIONALLY, THE REVIEW OF THE MANUFACTURING PROCESS NOTED NO SYSTEMIC ISSUES. THE PARTICULATE IS LARGER THAN THE ALLOWABLE SIZE ACCORDING TO THE PROCEDURE. THE MOST LIKELY CAUSE FOR THIS CONTAMINATION IS FLASHING ON THE SPATULA WAS SLOUGHED OFF AND CAPTURED IN THE SEALED POUCH DURING HANDLING AND TRANSIT AFTER PACKAGING.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED TO THE MFR AT THE TIME OF THIS REPORT. A F/U MEDWATCH WILL BE SUBMITTED, ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.