BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KALTOSTAT

    MDR report key: 15454028 · Received September 20, 2022

    Report

    Report Number
    1000317571-2022-00223
    Event Type
    Malfunction
    Date Received
    September 20, 2022
    Report Date
    August 26, 2022
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455122783
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - THIS EMDR IS BEING SUBMITTED TO INCLUDE THE BELOW: H6 - INVESTIGATION RESULTS UNDER IMDRF CAUSE INVESTIGATION CODE, IMDRF INVESTIGATION FINDINGS, IMDRF CAUSE CONCLUSIONS. H10: INVESTIGATION SUMMARY. A BATCH RECORD REVIEW WAS COMPLETED, AND NO DISCREPANCIES WERE FOUND. KALTOSTAT DRS 5X5CM (1X10PK) STER JP WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) 1021624 AND LOT NUMBER 1K03233 MANUFACTURED ON 08 NOVEMBER 2021. LOT # 1K03233 WAS STERILISED UNDER LOT 2173-24152A AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY STERIS. ALL RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS OF LOT 1K03233. THIS IS THE ONLY COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE. ONE PHOTOGRAPH AND THE ORIGINAL SAMPLE WERE RECEIVED FOR THIS ISSUE AND HAVE BEEN EVALUATED IN ACCORDANCE WITH WORK INSTRUCTIONS (WIS). THE PHOTOGRAPH CONFIRMED THE EXPECTED LOT NUMBER PRODUCT AND COMPLAINT ISSUE. THE ORIGINAL SAMPLE WAS REQUESTED FOR CHEMICAL IDENTIFICATION OF THE CONTAMINANT/FOREIGN MATTER. THE SAMPLE WAS REQUESTED ON 06 SEPT 2022 AND RECEIVED ON 13 SEPT 2022. A NON-CONFORMANCE RECORD WAS RAISED, AND AN INVESTIGATION COMPLETED TO IDENTIFY THE FOREIGN MATTER. AS THE SAMPLE WAS RETURNED FROM THE CUSTOMER, INVESTIGATION CONFIRMED THE FOREIGN MATTER WAS CONSISTENT WITH A POLYPROPYLENE BASED MATERIAL. FURTHER INVESTIGATION CONFIRMED THAT THE FOREIGN MATTER HAS ORIGINATED FROM THE POLYPROPYLENE CORES USED FOR KALTOSTAT REELSTOCK. THE ROOT CAUSE IS IDENTIFIED AS HUMAN ERROR DUE TO THE CORES NOT BEING MANUALLY DEBURRED TO RESULT IN THE FOREIGN MATTER REACHING THE FINAL PRODUCT PACK. A PROCEDURE IS IN PLACE FOR THE DEBURRING OF CORES, AND RETRAINING HAS BEEN COMPLETED FOR OPERATORS. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURES (SOPS). TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: REPORTING SITE: 1049092 MANUFACTURING SITE: 1000317571.

    Additional Manufacturer Narrative · 0

    COMPLAINANT STATE/PROVINCE: SHIZUOKA. COMPLAINANT COUNTRY: JAPAN. NAME OF DEALER: KYOWA-IKAKIKAI. BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED TO BE A REPORTABLE MALFUNCTION. TO DATE NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. FDA REGISTRATION NUMBER: (B)(4).

    Description of Event or Problem · 0

    TO DATE NO ADDITIONAL PATIENT OR EVENT DETAILS HAVE BEEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS FOREIGN MATTER INSIDE PRIMARY PACKAGE AND IT WAS OPENED BY CUSTOMER. THE PHOTOGRAPHS DEPICTING THE ISSUE WERE RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2625050 KALTOSTAT DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LTD 168210 1K03233 00768455122783

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown