BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3202674-005 REDIPAK 1P 10B 50C

    MDR report key: 13294243 · Received January 19, 2022

    Report

    Report Number
    1219103-2022-00345
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Report Date
    August 9, 2022
    Manufacturer
    CARDINAL HEALTH
    Product Code
    MKJ
    UDI-DI
    00681490580656
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD (DHR) FOR LOT 005523 WAS REVIEWED FOR BOTH THE FINISHED GOOD AND THE SUBASSEMBLIES MANUFACTURED AT THE PLANT, AND NO ABNORMAL PROCESS CONDITIONS WERE PRESENT DURING THE MANUFACTURING OF THE PRODUCTS THAT COULD HAVE LED TO THE REPORTED CONDITION. THE DHR REVIEW SHOWS THAT ALL ACCEPTANCE CRITERIA INSPECTIONS WERE WITHIN ACCEPTABLE LIMITS DURING THE PRODUCTION PROCESS. THIS INCLUDES TESTING WHERE THE LINER IS PEELED FROM THE GEL BODY ELECTRODE AND INSPECTED FOR DELAMINATION. THIS PRODUCT WAS MANUFACTURED BETWEEN 4-JUL-2020 AND 10-JUL-2020. A SAMPLE WAS RECEIVED IN THE FORM OF A PHOTO. THE PHOTO SHOWS THE OPEN PRODUCT AND THE PRODUCT POUCH. REVIEW OF THE PHOTO SHOWS GEL DELAMINATION IN THE UPPER MIDDLE OF THE PAD. THE GEL DELAMINATION DOES NOT CROSS OVER THE CARBON MAT AREA WHERE THE WIRES CONNECT TO THE PAD. GEL DELAMINATION OCCURS WHEN THE GEL-TO-RELEASE LINER BOND STRENGTH IS GREATER THAN THE COHESIVE STRENGTH OF THE GEL OR GREATER THAN THE GEL-TO-SUBSTRATE BOND STRENGTH. THE DIFFERENCE IN BOND STRENGTH CAN CAUSE THE GEL TO PEEL FROM THE SUBSTRATE AND/OR TEAR. DELAMINATION IS CATEGORIZED AS FOLLOWS: AN AESTHETIC DELAMINATION DEFECT IS CHARACTERIZED BY A PERMANENT SEPARATION OF THE HYDROGEL FROM THE SUBSTRATE, EXPOSING THE UNDERLYING CARBON VINYL WITH LITTLE (I.E., AREA LESS THAN 1/8-INCH X 1/8 INCH) OR NO HYDROGEL REMAINS ON THE RELEASE LINER. ALSO, NO SILVER/SILVER CHLORIDE INK IS EXPOSED. AESTHETIC DELAMINATION DEFECTS WILL NOT SIGNIFICANTLY AFFECT ELECTRODE FUNCTION BUT MAY DISPLEASE THE CLINICIAN. FUNCTIONAL DELAMINATION IS A PERMANENT SEPARATION OF THE HYDROGEL FROM THE SUBSTRATE SUCH THAT THE SILVER/SILVER CHLORIDE INK REMAINS EXPOSED. ADDITIONALLY, PER OUR PROCEDURE, THERE SHALL BE NO LESS THAN 55% HYDROGEL REMAINING ON THE ADULT ELECTRODE WHEN THE RELEASE LINER IS REMOVED FROM THE ELECTRODE. THERE SHALL BE NO LESS THAN 78% HYDROGEL REMAINING ON THE ADULT ELECTRODE, WHEN THE AREA OF SEPARATION INCLUDES THE AREA OF UNDERLYING CONDUCTIVE MAT. WITH LOSS OF THE HYDROGEL NO MORE THAN THE PERCENTAGES AS DEFINED ABOVE THE ELECTRODES RETAIN FUNCTIONALLY ESSENTIAL PERFORMANCE; HOWEVER, THE REDUCTION IN THE HYDROGEL AREA WITH THE SILVER/SILVER CHLORIDE INK BEING EXPOSED MAY CAUSE AN INCREASE IN CURRENT DENSITY ACROSS THE REMAINING GEL AREA. THIS INCREASES THE POTENTIAL FOR SKIN IRRITATION AND BURNS. FROM A ROOT CAUSE ANALYSIS PERSPECTIVE, IT WAS NOT POSSIBLE TO DETERMINE A SPECIFIC ROOT CAUSE. AS INDICATED ON THE PRODUCT PACKAGING PROPER STORAGE AND USAGE OF THE ELECTRODES IS CRITICAL TO THE PERFORMANCE OF THE GEL. THE ELECTRODES SHOULD BE STORED IN THEIR SEALED PROTECTIVE POUCH IN A COOL, DRY PLACE AND OUT OF DIRECT SUNLIGHT. DO NOT OPEN PACKAGE UNTIL READY FOR USE. DO NOT BEND, FOLD, OR PUNCTURE THE PACKAGING. IMPROPER STORAGE CONDITIONS AND/OR HANDLING OF THE PRODUCT MAY COMPROMISE GEL PROPERTIES PRIOR TO THE EXPIRATION. DUE TO NOT BEING ABLE TO VERIFY THAT THE CAUSE OF THE DELAMINATION IS MANUFACTURING RELATED THERE WILL BE NO CORRECTIVE/PREVENTIVE ACTIONS AT THIS TIME. WE WILL CONTINUE TO TREND THIS ISSUE FOR FUTURE OCCURRENCES AS PART OF THE COMPLAINT REVIEW PROCESS.

    Additional Manufacturer Narrative · 0

    UPDATED SECTION D2 PRODUCT CODE FROM DRO TO MKJ.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THE ELECTRODE EXHIBITED DELAMINATION. PER ADDITIONAL INFORMATION RECEIVED, THE DELAMINATION OCCURRED BEFORE USE ON THE PATIENT AND THERE WAS NO IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848166 3202674-005 REDIPAK 1P 10B 50C AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ CARDINAL HEALTH PM20022 005523 00681490580656
    804407 3202674-005 REDIPAK 1P 10B 50C AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) MKJ CARDINAL HEALTH PM20022 005523 00681490580656

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown