BARD-PARKER STAINLESS STEEL BLADES SIZE 11, STERILE

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION, AND NO PHOTOS OF THE BROKEN BLADES WERE PROVIDED. ADDITIONALLY, WE RECEIVED NO RESPONSES AFTER REACHING OUT FOR ADDITIONAL INFORMATION. THE COMPLAINT COULD NOT BE CONFIRMED, AND NO ROOT CAUSE WAS ESTABLISHED. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

COMPLAINANT ALLEGES "THE OR OPENED 1 BLADE SINGLE PACKAGE AND PLACED ON A #7 HANDLE AND WHEN USED THE BLADE BROKE IN HALF. ANOTHER BLADE WAS OPENED AND PLACED ON THE #7 HANDLE IN SIMILAR FASHION AND AGAIN BROKE IN HALF WHEN WAS ATTEMPTED TO BE USED. SAME LOT."