BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASEPT

    MDR report key: 17238686 · Received June 30, 2023

    Report

    Report Number
    3005704822-2023-00002
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    May 22, 2023
    Report Date
    June 23, 2023
    Manufacturer
    PFM MEDICAL MEPRO GMBH
    Product Code
    DWM
    PMA / PMN Number
    K093307
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A THOROUGH INVESTIGATION WAS CONDUCTED TO ASSESS THE POTENTIAL CAUSES OF THE COMPLAINT RELATED TO LOT# 2302-027 OF THE EU ASEPT PLEURAL AND PERITONEAL DRAINAGE PRODUCT. THE FOLLOWING STEPS WERE TAKEN: DEVICE HISTORY RECORD (DHR) REVIEW: A COMPREHENSIVE REVIEW OF THE DHR FOR LOT# 2302-027 WAS PERFORMED, AND NO DEVIATIONS OR NON-CONFORMANCES WERE FOUND. THE MANUFACTURING PROCESS FOR THIS SPECIFIC LOT FOLLOWED ALL ESTABLISHED PROCEDURES AND MET THE REQUIRED SPECIFICATIONS. REVIEW OF PREVIOUS RELEASES: A METICULOUS EXAMINATION OF PREVIOUS RELEASES OF THE SAME PRODUCT WAS CONDUCTED. THE OBJECTIVE WAS TO IDENTIFY ANY POTENTIAL RECURRING ISSUES OR DEVIATIONS IN THE MANUFACTURING PROCESS. NO DEVIATIONS WERE FOUND, INDICATING THAT THE PRODUCTION OF THE EU ASEPT PLEURAL AND PERITONEAL DRAINAGE PRODUCT HAS BEEN CONSISTENT AND IN COMPLIANCE WITH QUALITY STANDARDS. ENVIRONMENTAL DATA ANALYSIS: TO ENSURE THE PRODUCT'S INTEGRITY, THE ENVIRONMENTAL DATA DURING THE MONTH OF THE PRODUCT'S MANUFACTURING DATE WAS THOROUGHLY REVIEWED. NO ANOMALIES OR IRREGULARITIES WERE IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE MANUFACTURING ENVIRONMENT WAS FOUND TO BE WITHIN THE ACCEPTABLE RANGE OF CONDITIONS. VIABLE/NON-VIABLE TESTING: THE VIABLE/NON-VIABLE TESTING PERFORMED IN THE CLEANROOM IN JANUARY WAS EVALUATED TO VERIFY COMPLIANCE. THE RESULTS INDICATED THAT ALL REQUIREMENTS WERE MET, WITH NO DEVIATIONS IDENTIFIED DURING THE TESTING PROCESS. THIS FURTHER STRENGTHENS THE CONCLUSION THAT THE DESCRIPTION OF THE COMPLAINT IS NOT ATTRIBUTED TO THE MANUFACTURING PROCESS. DESPITE CONDUCTING THESE INVESTIGATIONS, THE ROOT CAUSE OF THE COMPLAINT COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE REPORTED ISSUE WAS AN ISOLATED INCIDENT OR RESULTED FROM EXTERNAL FACTORS NOT DIRECTLY RELATED TO THE MANUFACTURING PROCESS OR PRODUCT QUALITY. ADDITIONAL INFORMATION OR EVIDENCE MAY BE REQUIRED TO FURTHER INVESTIGATE AND PINPOINT THE EXACT CAUSE OF THE COMPLAINT. REVIEW OF SIMILAR COMPLAINTS FROM 2020-2022: NO SIMILAR COMPLAINTS WERE RECORDED DURING THE PERIOD FROM 2020 TO 2022, INDICATING THAT THIS SPECIFIC COMPLAINT IS AN ISOLATED INCIDENT. TOTAL SALES OF EU ASEPT PLEURAL AND PERITONEAL DRAINAGE (2020-2022): DURING THE PERIOD FROM 2020 TO 2022, A TOTAL OF (B)(4) UNITS OF EU ASEPT PLEURAL AND PERITONEAL DRAINAGE WERE SOLD. OCCURRENCE RATE: THE OCCURRENCE RATE OF THE COMPLAINT IN QUESTION IS CALCULATED TO BE (B)(4), INDICATING THAT THE COMPLAINT IS RARE AND HAS A LOW FREQUENCY OF OCCURRENCE. REVIEW OF RISK ANALYSIS: WITHIN THE RISK ANALYSIS, A SPECIFIC RISK WAS IDENTIFIED. B)(4) THIS SUGGESTS THAT THE IDENTIFIED RISK IS NOT OCCURRING AT A CONCERNING RATE. INFORMATION WAS PROVIDED THAT THE INFECTION OCCURRED 14 DAYS AFTER IMPLANTATION OF THE CATHETER AT THE CATHETER EXIT SITE WHICH INDICATES THAT THE INFECTION DID NOT OCCUR FROM THE IMPLANTATION PROCEDURE BUT LIKELY FROM THE CONTINUED MAINTENANCE OF THE CATHETER INCLREADY CLEANING AND DRESSING CHANGES. BASED ON THE INVESTIGATION RESULTS AND THE AVAILABLE DATA, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT. THE LOW OCCURRENCE RATE OF THE COMPLAINT AND THE ABSENCE OF SIMILAR COMPLAINTS IN PREVIOUS YEARS INDICATE THAT THIS MAY BE AN ISOLATED INCIDENT RATHER THAN A SYSTEMIC ISSUE.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED FROM A HOSPITAL REGARDING THE ASEPT PLEURAL DRAINAGE SYSTEM (P09080001). THE HOSPITAL STATES THAT OUT OF 50 PATIENTS, 17 DEVELOPED AN INFECTION AT THE CATHETER. INFECTION OCCURRED 14 DAYS AFTER IMPLANTATION OF THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321062 ASEPT PLEURAL DRAINAGE CATHETER DWM PFM MEDICAL MEPRO GMBH P09080001B 2302-027

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other