BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0750 - DUODERM

    MDR report key: 12015293 · Received June 17, 2021

    Report

    Report Number
    9618003-2021-01165
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Report Date
    May 25, 2021
    Manufacturer
    CONVATEC DOMINICAN REPUBLIC INC
    Product Code
    NAD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). BATCH RECORD REVIEW: LOT 0D01660 WAS MANUFACTURED ON 04/26/2020, PRODUCT DESCRIPTION DUODERM XTHIN DRS 15X15CM (1X10PK) NAI IN BODOLAY LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. A BATCH RECORD REVIEW WAS PERFORMED ON 07/08/2021, 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. THE BATCH RECORD REVIEW SUPPORTS THAT THERE WERE NO DISCREPANCIES RELATED TO THE ISSUE REPORTED. PHOTOGRAPH, VIDEO AND/OR PHYSICAL SAMPLE EVALUATION: THERE ARE PHOTOGRAPHS ASSOCIATED WITH THIS CASE AND IN THESE, THE REPORTED DEFECT CAN BE SEEN. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED IN THE ANALYSIS PHASE CONCLUSIONS, THE ISSUE OF WND-PMC 9.6 PRIMARY PACK HAS INCOMPLETE OR OPEN SEAL / WELD, OR IS TORN, RIPPED OR CONTAINS HOLES OR EXHIBITS EXTERNAL CONTAMINATION, OR DRESSING OR LOOSE MATERIAL IS TRAPPED IN PACKAGING, FOR PRODUCTS MANUFACTURED AT BODOLAY PRATT C PACKAGING LINE, ARE ATTRIBUTED TO THE FOLLOWING PROBABLE CAUSES PER FAILURE MODE: 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. A CAPA PLAN WAS GENERATED FOR MITIGATE THE ROOT CAUSES IDENTIFIED. 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

    DEVICE 2 OF 2. (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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DIRT FOUND ON THE PACKAGE. 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
    914447 L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187957 0D01660

    Patients

    Seq Age Sex Outcome Treatment
    1