AESCULAP

Additional Manufacturer Narrative

THE ADVERSE EVENT IS FILED UNDER (B)(4). INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

Description of Event or Problem

AS REPORTED BY THE FACILITY: "WE HAD MULTIPLE BAGS OF FILTERS WITH WEAK SPOTS OR PIN HOLES IN THEM. WE DID A ROOT CAUSE ANALYSIS AND COULD LOCATE A CAUSE FROM THE TRAYS INVESTIGATED." NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Additional Manufacturer Narrative

THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). THE SAMPLES PROVIDED WERE SENT TO THE MANUFACTURING SITE FOR EVALUATION AND THE RESULTS OF THE INVESTIGATION CONFIRMED THAT THE SAMPLES SHOW BLACK MARKS AND POTENTIAL MICRO HOLES. THE BLACK SPOTS ARE CONSIDERED A COSMETIC DEFECT. THE POTENTIAL ROOT CAUSE FOR THE BLACK MARKS ON THE INDICATOR DOT, THE BLACK INK LOOKS TO BE THE SAME INK USED FOR THE TEXT ON THE FACE OF THE FILTER IN MANUFACTURING. THE SOURCE OF THE BLACK MARKS IS LIKELY A CLUMP OF DEBRIS WITH INK OR SOME PARTIALLY DRIED INK THAT ATTACHED TO THE PRINT PLATES. FOR THE WEAK SPOTS, THE RAW MATERIAL SUPPLIER IS AN ISO 13485 CERTIFIED SUPPLIER FOR STERILIZATION PACKAGING AND INFECTION CONTROL MATERIAL AND TESTS EACH LOT OF THIS FILTER MATERIAL FOR POROSITY, PERMEABILITY, AND WATER REPELLENCY.