BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L3W0750 - DUODERM

    MDR report key: 12517985 · Received September 23, 2021

    Report

    Report Number
    9618003-2021-02294
    Event Type
    Malfunction
    Date Received
    September 23, 2021
    Report Date
    September 2, 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

    BATCH RECORD REVIEW: LOT 0C04466 WAS MANUFACTURED ON 04/07/2020, IN UHLMAN #2 LINE, WITH A TOTAL OF (B)(4) MARKET UNITS. A BATCH RECORD REVIEW WAS PERFORMED ON 05/10/2021, 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: NO PHOTO RELATED TO THE REPORTED PROBLEM IS AVAILABLE FOR EVALUATION. CONCLUSION SUMMARY OF THE RELATED EVENT: BASED ON THE INVESTIGATION FINDINGS, THE FOLLOWING ROOT CAUSES WERE FOUND PER LINE AND FAILURE MODE REPORTED: UHLMANN #2 LINE, PACKAGING TORN/CRUSHED: MATERIAL, FILM/PAPER WITH HOLES AND FOLD/CREASES: FOR THE FILM IMPACTED IT WAS PERCEIVED THAT IT DOES NOT HAVE A UNIFORM COLORING. IT WAS DEMONSTRATED THAT THE ASPECT OF ¿WRINKLES¿ ON THE PRODUCT WHEN USING THE DECOLOURED FILM. THEREFORE, IT IS REQUIRED TO RAISE A NOTIFICATION TO THE FILM SUPPLIER IN ORDER TO IMPROVE THE MANUFACTURING PROCESS OF IT AND AVOID A POOR VISUAL APPEARANCE ON THE FINAL PRODUCT. ON THE OTHER HAND, PAPER MATERIAL PRESENTED NO SCARS NOR PROBLEMS DURING MANUFACTURING PROCESS. NO HOLES NOR WRINKLES WERE PERCEIVED. MACHINE, LOOSE PUSH TOOLING FROM THE MACHINE ARM: IT WAS DEMONSTRATED THAT IF THE PUSH TOOLING OF THE CARTONER MACHINE ARM IS LOOSE, IT DOES NOT STAY PARALLEL TO THE BLISTER BORDER DURING OPERATION, INSTEAD IT CREATES AND ANGLE RELATED TO THE BLISTER BORDER, CAUSING THE BLISTER PACKS NOT TO ENTER COMPLETELY INSIDE THE PREFORMED MKU. AS A RESULT, THE CARTONER WILL TRY TO CLOSE THE MKU DAMAGING THE BLISTER THAT WERE NOT COMPLETELY INSIDE OF IT. MACHINE, POSITION OF SENSOR TO DETECT BLISTER OUT OF THE BOX: ON THE CARTONER MACHINE, THERE IS A SENSOR THAT DETECTS IF A BLISTER IS NOT COMPLETELY INSIDE THE MKU. IF A BLISTER IS NOT COMPLETELY INSIDE DE MKU THEN THE SENSOR DETECTS IT AND STOPS THE MACHINE PRIOR TO START THE NEXT STAGE OF THE PROCESS WHICH IS CLOSING THE FLAPS OF THE CARTON, THAT COULD LEAD INTO A DAMAGED BLISTER. IT WAS DEMONSTRATED THAT IF THE SENSOR IS NOT ON THE RIGHT POSITION IT WILL NOT DETECT THE BLISTER. THE SENSOR IS OVER A BASE THAT GETS LOOSE OVER TIME. MACHINE, FLAP CARTON TOOLING TOO RIGID: CLOSURE OF THE FLAP CARTON IS THE NEXT PROCESS STEP ON THE CARTONER MACHINE AFTER INSERTING THE BLISTER ONTO THE MKU. IT WAS DETECTED THAT THE TOOLING OF THE FLAP CARTON IS TOO RIGID, SO IF A BLISTER IS NOT COMPLETELY INSIDE THE MKU IT COULD BE DAMAGED IF THE CARTONER TRIES TO CLOSE THE FLAP OF THE CARTON. THE CAPA PLAN TW#(B)(4) 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.

    Additional Manufacturer Narrative · 0

    (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 · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS PINHOLE ON THE PRIMARY PACKAGING OF THE PRODUCT. THE PRODUCT WAS NOT USED ON PATIENT. NO PHOTO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1420118 L3W0750 - DUODERM DRESSING,WOUND,OCCLUSIVE NAD CONVATEC DOMINICAN REPUBLIC INC 187662 0C04466

    Patients

    Seq Age Sex Outcome Treatment
    1