SINGLE USE PAPER FILTER WITH INDICATOR

Additional Manufacturer Narrative

MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PRODUCT JK095, SINGLE USE PAPER FILTER WITH INDICATOR. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING THE INSPECTION OF FILTERS IN A CONTAINER USED IN THE OPERATING ROOM, STAFF OBSERVED SIGNS OF PUNCTURE ON ONE SURFACE. NO ALTERNATIVE CONTAINER WAS AVAILABLE, THEREFORE SURGICAL PROCEDURE WAS POSTPONED. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS CONSIDERED REPORTABLE FOR THE FOLLOWING REASON - MALFUNCTION (NOT LATER THAN 30 DAYS). THE ASSESSMENT FOR THE REPORTABILITY OF THIS MALFUNCTION WAS BASED ON THE REVIEW OF THE APPLICABLE RISK ANALYSIS. ADDITIONAL INFORMATION WAS NOT PROVIDED. THE MALFUNCTION IS FILED UNDER AESCULAP AG REFERENCE NO. (B)(4).

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: H3 - YES, EVALUATION. H6 - CODES UPDATED. INVESTIGATION RESULTS: THE COMPLAINED PRODUCT WAS MADE AVAILABLE FOR INVESTIGATION. THE MANUFACTURER RECEIVED THE PRODUCT IN A USED CONDITION. VISUAL EXAMINATION OF THE PRODUCT IDENTIFIED AREAS WITH REDUCED LAYER THICKNESS AS WELL AS LOCALLY ENLARGED PORES ON THE SURFACE. ADDITIONALLY, SAMPLES TAKEN FROM WAREHOUSE SUBSEQUENTLY UNDERWENT VISUAL EXAMINATION, WHICH LIKEWISE SHOWED THE PRESENCE OF ENLARGED PORES AND THIN AREAS TOO. BOTH THE COMPLAINT SAMPLES AND THE SAMPLES FROM THE WAREHOUSE WERE EVALUATED FOR AIR PERFORMANCE USING VALIDATED TEST METHODS. THE RESULTS DEMONSTRATED THAT THINNED LAYER AREAS DID NOT ADVERSELY AFFECT AIR PERFORMANCE WHEN COMPARED WITH NON-THIN AREAS. NO INCREASED PERMEABILITY OR INDICATIONS OF REDUCED BARRIER FUNCTION WERE OBSERVED. FURTHERMORE, PORE SIZES WERE ASSESSED IN ACCORDANCE WITH THE APPLICABLE STANDARDS FOR STERILIZATION MATERIALS. THE EVALUATION CONFIRMED THAT THE POROSITY COMPLIED WITH THE SPECIFIED REQUIREMENTS. BATCH HISTORY REVIEW: BASED ON THE INVESTIGATION FINDINGS AND THE AVAILABLE INFORMATION, NO DEVIATIONS WERE DETECTED. THE PRODUCT COMPLIED WITH THE SPECIFICATIONS WHICH WERE VALID AT THE TIME OF PRODUCTION. ACCORDING TO MANUFACTURER'S REPORTING EVALUATION IN ACCORDANCE WITH 21 CFR PART 803, SECTION 803.3, THIS EVENT IS NOT REPORTABLE FOR THE FOLLOWING REASON: - NO SERIOUS PUBLIC HEALTH THREAT / FALSIFIED DEVICE. - NO SERIOUS INCIDENT. - NO MALFUNCTION. CONCLUSION/PREVENTIVE MEASURES: THE MANUFACTURER CONFIRMES THAT THE IDENTIFIED THIN LAYER AREAS ON THE PRODUCTS ARE ATTRIBUTABLE TO INHERENT CHARACTERISTICS OF THE RAW MATERIAL MANUFACTURING PROCESS. THESE VARIATIONS REMAIN WITHIN SPECIFICATION AND DO NOT AFFECT COMPLIANCE WITH THE DEFINED MATERIAL REQUIREMENTS. FURTHERMORE, THE MANUFACTURER CONFIRMS, THAT NO STATISTICALLY SIGNIFICANT INCREASE IN THE FREQUENCY OR SEVERITY OF THE REPORTED FAILURE HAS BEEN IDENTIFIED. MOREOVER, A REVIEW OF MANUFACTURER`S POST-MARKET SURVEILLANCE DATABASE REVEALED THAT THERE ARE NO SIMILAR SERIOUS INCIDENTS INVOLVING THE AFFECTED ARTICLE NUMBER DURING THE PERIOD FROM JANUARY 2022 UNTIL DECEMBER 2025. NO FAILURE WAS DETECTED. PRODUCT WORKS AS INTENDED.