AESCULAP

Description of Event or Problem

IT WAS REPORTED THAT THERE WERE PIN HOLES OBSERVED IN THE FILTERS. WHEN THE FILTERS ARE HELD UP TO THE LIGHT AND EXAMINED WITH THE NAKED EYE, THE BLUE COLOR SEEMS VARIED AND THERE ARE WHITE SPOTS THAT ARE EITHER VARIATION IN THE MATERIAL (IN THE NAP OR FILTER WEAVE PATTERN, A THINNER KNAP) OR 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 (B)(4). ADDITIONAL INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER DATE. FOUR HUNDRED NINETY SEVEN (497) SAMPLES PROVIDED WERE RETURNED TO THE MANUFACTURING SITE FOR TECHNICAL EVALUATION. RESULTS OF THE INVESTIGATION DETERMINED THAT THERE WERE NO DEFECTS OR DAMAGES OBSERVED ON THE FILTERS. THE FILTERS RETURNED WERE UNPROCESSED. BASED ON THE INVESTIGATION FINDINGS, THE PRODUCT MET SPECIFICATION. AS A RESULT, THE REPORTED FAILURE COULD NOT BE CONFIRMED TO BE A MANUFACTURING RELATED ISSUE. THE RAW MATERIAL SUPPLIER IS (B)(4) CERTIFIED SUPPLIER FOR STERILIZATION PACKAGING AND INFECTION CONTROL MATERIAL AND TESTS EACH LOT OF THIS FILTER MATERIAL FOR POROSITY, PERMEABILITY, AND WATER REPELLENCY.