BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG

    MDR report key: 3193170 · Received June 25, 2013

    Report

    Report Number
    1419937-2013-00330
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDELA INC
    Product Code
    HGX
    PMA / PMN Number
    K031614
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A REPLACEMENT POWER SUPPLY WAS SENT TO THE CUSTOMER. ATTEMPTS TO F/U WITH THE CUSTOMER TO OBTAIN ADD'L INFO REGARDING THIS EVENT WERE UNSUCCESSFUL. INCLUDING, A FINAL ATTEMPT WAS SENT BY LETTER. THE PRODUCT INVOLVED IN THE COMPLAINT WAS NOT RETURNED FOR EVAL/INVESTIGATION. THEREFORE, NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT AT THIS TIME. SHOULD ADD'L INFO OR THE ORIGINAL PRODUCT BE REC'D, RESULTING IN NEW, CHANGED, OR CORRECTED INFO, A F/U REPORT WILL BE FILED AT THAT TIME. THIS ISSUE WITH THE DAMAGED TRANSFORMER HOUSING FOR THE PUMP IN STYLE DEVICE WAS ADDRESSED IN INVESTIGATION (B)(4). THE INVESTIGATION FOUND THAT THE TRANSFORMERS ARE BEING DAMAGED DURING SHIPMENT FROM THE MFR TO MEDELA. THIS DAMAGE IS CAUSING THE PLASTIC HOUSING TO FAIL PREMATURELY WHEN SUBJECTED TO NORMAL USE AND FORESEEABLE MISUSE. THE PACKAGING USED BY THE MFR TO SHIP THE TRANSFORMERS TO MEDELA IS NOT ROBUST ENOUGH TO HANDLE ALL OF THE POTENTIAL SHIPPING, HANDLING, AND ABUSE CONDITIONS THAT COULD ARISE FROM LOGISTICS OF THE CONSOLIDATION PROCESS. AS A RESULT OF THE INVESTIGATION, THE SHIPPING AND CONSOLIDATION PROCESS HAS BEEN MODIFIED TO REDUCE THE HANDLING AND POTENTIAL FOR DOUBLE STACKING OF THE SKIDS. THE SHIPPING PACKAGING STRENGTH HAS ALSO BEEN INCREASED TO FURTHER PROTECT THE TRANSFORMERS DURING SHIPPING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE HOUSING OF THE PUMP IN STYLE TRANSFORMER HOUSING WAS COMING OFF AND SHE COULD SEE THE INSIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288801 PUMP IN STYLE ADVANCED BREAST PUMP METRO BAG HGX MEDELA INC 57036/9207010 REV L/2011

    Patients

    Seq Age Sex Outcome Treatment
    1