AESCULAP

Description of Event or Problem

ACCORDING TO THE CUSTOMER: " WE ARE HAVING ISSUES WITH HOLES IN AESCULAP FILTERS. THIS IS AN EVERYDAY OCCURRENCE. WE, IN SPD, HAVE RECOMMENDED EVERYTHING POSSIBLE TO AVOID CREATING HOLES IN FILTERS. I DO UNDERSTAND THERE ARE AREAS IN THE FILTERS THAT ARE LIGHT AND CAN LOOK LIKE HOLE IN FILTER BUT WE ARE RECEIVING REPORTS OF TINY HOLES. I DID INSPECT A NEW BAG. I PUT IT UP AGAINST A LIGHTED MAGNIFIER. THERE ARE AREAS THAT LOOK LIKE TINY PIN HOLES."

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC (B)(4) CC (B)(4). CORRECTION: G4 510K NUMBER CORRECTED. ADDITIONAL INFORMATION: H10 RELATED REPORT NUMBERS INVESTIGATION RESULTS NINE (9) SAMPLES AND TWO (2) PHOTOGRAPHS PROVIDED WERE RETURNED TO THE MANUFACTURING SITE FOR TECHNICAL EVALUATION. RESULTS OF THE INVESTIGATION DETERMINED THAT POTENTIAL MICRO-HOLES WERE OBSERVED IN THE FILTERS. THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS (DHR) REVIEW FOUND THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION. THERE ARE NO SIMILAR COMPLAINTS AGAINST THE REPORTED LOT NUMBERS WITH THIS ERROR PATTERN. BASED ON THE INVESTIGATION FINDINGS, THE PRODUCT MET SPECIFICATIONS. AS A RESULT, THE REPORTED FAILURE COULD NOT BE CONFIRMED TO BE A MANUFACTURING RELATED ISSUE. THE SUPPLIER IS A RAW MATERIAL SUPPLIER IS AN INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (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.