BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0250 - KALTOSTAT

    MDR report key: 15181887 · Received August 8, 2022

    Report

    Report Number
    1000317571-2022-00140
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Report Date
    July 13, 2022
    Manufacturer
    CONVATEC LTD
    Product Code
    NAC
    UDI-DI
    00768455122790
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINANT STATE/PROVINCE: (B)(6). COMPLAINANT COUNTRY: (B)(6). DEALER: (B)(6). 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 REPORTING SITE: (B)(4). MANUFACTURING SITE: (B)(4).

    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. A BATCH RECORD REVIEW WAS COMPLETED AND NO DISCREPANCIES WERE FOUND. KALTOSTAT DRS 7.5X12CM (1X10PK) STER JP WAS MANUFACTURED UNDER SYSTEM APPLICATION PRODUCT (SAP) CODE 1021632 AND MANUFACTURING LOT NUMBER 1G02913 ON 01 SEPTEMBER 2021. LOT 1G02913 WAS STERILISED UNDER LOT 2173-22081A AND RELEASED ON REVIEW OF RESULTS OF STERILISATION PROVIDED BY STERILISATION COMPANY STERIS. ALL OF THE RESULTS WERE WITHIN SPECIFICATION AND PRODUCTS WERE RELEASED. NO NONCONFORMITY WAS IDENTIFIED DURING THE MANUFACTURING PROCESS OF LOT 1G02913. THIS IS THE SECOND COMPLAINT FOR THE AFFECTED LOT REGISTERED WITHIN DATABASE, THE OTHER COMPLAINT BEING FOR ¿DRESSING MESSED IN PACKAGE¿. ONE PHOTOGRAPH WAS RECEIVED FOR THIS ISSUE AND HAS BEEN EVALUATED IN ACCORDANCE WITH PER WORK INSTRUCTIONS (WI). THE PHOTOGRAPH CONFIRMS THE EXPECTED LOT NUMBER, PRODUCT AND THE COMPLAINT ISSUE WHERE THE DRESSING IN SEAL IS EVIDENT. A NONCONFORMANCE WAS OPENED FOR THIS COMPLAINT ISSUE. A DATA REVIEW WAS RAISED, BUT AS OTHER COMPLAINTS AND NON-CONFORMANCES HAD BEEN RAISED FOR SIMILAR FAILURES ON DOYEN 2, AN OLDER INVESTIGATION WAS STILL RELEVANT FOR THIS ISSUE AND FAILURE MODE. THIS INVESTIGATION, COMPLETED IN SEPTEMBER 2021, IDENTIFIED A POOR NIP ROLLER DRIVE CAUSING MATERIAL POSITIONING ISSUES, AND NOT DETECTED DUE TO A CROSS SCENE ILLUMINATION VARIANCE. AS THE AFFECTED BATCH WAS MANUFACTURED 01 JULY 2021, THE BATCH IS WITHIN THE INVESTIGATION BOUNDING DATES. IMPROVEMENTS TO THE LINE ARE BEING MADE UNDER AN OPEN CORRECTIVE AND PREVENTIVE ACTIONS (CAPA). THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS, STANDARD OPERATING PROCEDURE (SOP). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIMARY PACKAGE WAS SEALED WITH PRODUCT. THE DEVICE WAS NOT USED BY END USER. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM COMPLAINANT.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2531983 L3W0250 - KALTOSTAT DRESSING,WOUND,HYDROPHILIC NAC CONVATEC LTD 168212 1G02913 00768455122790

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown