BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0750 - DUODERM

    MDR report key: 11647909 · Received April 12, 2021

    Report

    Report Number
    9618003-2021-00683
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Report Date
    March 17, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION (G1) - CONTACT OFFICE ADDRESS: (B)(4). BATCH RECORD REVIEW: LOT 9L02456 WAS MANUFACTURED ON 11/21/2019 IN THE BODOLAY LINE WITH A TOTAL OF (B)(4) MARKET UNITS. COMPLAINT INVESTIGATOR ID 5173 PERFORMED A BATCH RECORD REVIEW ON 04/30/2021 TO VERIFY IF ALL THE APPLICABLE PROCEDURES WERE FOLLOWED AND NO ISSUES WERE FOUND; ALL THE COMPONENTS FOR ASSEMBLY WERE CORRECT PER BOM AND ALL THE TOOLING INFORMATION DOCUMENTED WAS ALSO CORRECT, UNDER ICC CODE 187957 SAP MATERIAL ID 1704769 AND MANUFACTURING ORDER (B)(4). THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. RETURNED SAMPLE EVALUATION: PHOTO RELATED TO THE REPORTED PROBLEM IS AVAILABLE FOR EVALUATION. INVESTIGATION SUMMARY: BASED IN THE ANALYSIS PHASE CONCLUSIONS. FOR EXTRA MATERIAL IN SEAL OR FOREIGN MATTER THE ROOT CAUSES FOUND WERE: MANPOWER: INCORRECT DRESSING INSPECTION: RESIDUES OF PAPER AND FILM STICK TO DRESSING AFTER ELC (EXTRUSION LAMINATION AND CUTTING) PROCESS, SINCE THE SCRAP COLLECTOR IS ABOVE THE DRESSING WEB. SINCE DRESSINGS ARE AUTOMATICALLY FEED IN THE BODOLAY MACHINE, THE UNITS ARE PACKAGED WITHOUT THE OPERATOR AND VISION SYSTEM NOTICING. AN OPPORTUNITY WAS FOUND RELATED TO THE INSPECTION PROCESS PERFORMED BY THE ELC 10 AND ELC 11 SINCE DRESSINGS MUST BE INSPECTED 100% AS PER APPLICABLE PI31-103 VER 17.0 AND PI31-141 VER 7.0. FOR DIRTY ON PACKAGE (BLACK STAIN) THE ROOT CAUSES FOUND WERE: METHOD: UNCLEAR STEPS TO PERFORM ONLINE REWORK: AN OPPORTUNITY WAS FOUND SINCE THERE IS NOT A STANDARDIZED METHOD FOR THE SEGREGATION AND/OR REWORK OF THE BLISTERS AFTER HAVING A FAILURE OR BREAKDOWN ON THE CARTONER MACHINE. WRONG PLACEMENT OF BLISTERS (METHOD). DURING THE INDEXATION PROCESS OF BLISTERS FROM THE PRIMARY PACKAGING TO SECONDARY PACKAGING, NOT ALL BLISTERS ARE NOT ORGANIZED INTO THE COUNTER POCKETS. IT IS A MANUAL PROCESS. THIS ISSUE CAUSES THAT THE BLISTERS DO NOT ENTER ON THE MKU¿S, CREATING DEFECTS SUCH AS TORN OR CRUSHED OR DIRTY PACKAGE. 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

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

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BLACK BLOTCH AT THE EDGE OF DRESSING. THE PRODUCT WAS NOT USED ON PATIENT. A PHOTOGRAPH DEPICTING THE ISSUE WAS RECEIVED FROM THE COMPLAINANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545455 L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187957 9L02456

    Patients

    Seq Age Sex Outcome Treatment
    1