BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUODERM

    MDR report key: 16769842 · Received April 19, 2023

    Report

    Report Number
    9618003-2023-00322
    Event Type
    Malfunction
    Date Received
    April 19, 2023
    Date of Event
    February 10, 2023
    Report Date
    March 30, 2023
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    UDI-DI
    00768455150922
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: (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: 1049092. MANUFACTURING SITE: 9618003.

    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 BATCH RECORD REVIEW: LOT 1K00164 WAS MANUFACTURED ON 07/OCT/2021, IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS (MKUS). COMPLIANCE ENGINEER PERFORMED A BATCH RECORD REVIEW ON 15/JUN/2023, TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BILL OF MATERIALS (BOM) AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, SYSTEM APPLICATION PRODUCT (SAP) MATERIAL IDENTIFICATION (ID) 1704768 AND MANUFACTURING ORDER (B)(4). THEREFORE, NO DISCREPANCY RELATED TO THIS ISSUE WERE FOUND WITHIN THE DOCUMENTATION. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE NO PHOTOGRAPHS ASSOCIATED WITH THIS CASE. NO UNUSED RETURN SAMPLE WAS EXPECTED. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE REVISION OF THE OBSERVATION OF THE PROCESSES INVOLVED, INTERVIEWS TO THE PERSONNEL OF THE LINE AND THE EXPERTISE OF THE TRIAGE TEAM, THIS FAILURE MODE WAS ATTRIBUTED TO THE FOLLOWING PROBABLE CAUSES: METHOD ¿ DIRTY CARTS TO TRANSPORT MATERIALS. ¿ DIRTY TRAYS. ¿ MIXERS WITH RESIDUES FROM PREVIOUS MIXTURES MANPOWER: ¿ INADEQUATE TRANSFER OF MATERIALS. MANPOWER: ¿ INADEQUATE ELECTROCUTING LAMP MAINTENANCE CORRECTIVE AND PREVENTIVE ACTIONS IDENTIFIED WILL BE TAKEN THROUGH CORRECTIVE/PREVENTATIVE ACTION (CAPA) RECORD IN DATABASE. THE INVESTIGATION ASSOCIATED WITH RELATED EVENT RECORD HAS BEEN APPROVED AND IS COMPLETE. NO ADDITIONAL ACTION IS REQUIRED, AND THIS COMPLAINT WILL BE CLOSED. THIS ISSUE WILL BE MONITORED THROUGH THE POST MARKET PRODUCT MONITORING REVIEW PROCESS. 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: 9618003.

    Description of Event or Problem · 0

    THE NURSE REPORTED THAT WHEN SHE APPLIED THE COMPANY'S KNOWN HYDROCOLLOID DRESSING TO THE PATIENT ON (B)(6) 2023, SHE HAD FOUND A BLUE FOREIGN MATTER IN THE MIDDLE OF THE DRESSING. THE PRODUCT WAS NOT USED ON PATIENT. THE PRODUCT WAS NOT RETURNED AND IT HAD BEEN DISCARDED. NO PHOTO WAS AVAILABLE AT THIS TIME.

    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
    1602161 DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187955 1K00164 00768455150922

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown