BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDELA PUMP AND SAVE BREAST PUMP BAGS

    MDR report key: 1372223 · Received April 24, 2009

    Report

    Report Number
    MW5010894
    Event Type
    Malfunction
    Date Received
    April 24, 2009
    Date of Event
    March 23, 2009
    Report Date
    May 5, 2009
    Manufacturer
    MEDELA, INC.
    Product Code
    HGY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    RPTR IS A MOM, IN LATE 2008. WAS USING "PUMP AND SAVE" BREAST MILK STORAGE BAGS (50 - COUNT BOX) TO STORE HER BREAST MILK IN FREEZER AFTER PUMPING. SHE WAS PUMPING ONCE A DAY AND OPENED THE BOX IN 2009. HALF WAY THROUGH THE BOX, A SECTION OF THE BAGS STUCK TOGETHER. SHE PULLED ONE, AND THEY CAME OUT STUCK TOGETHER. SHE NOTED A WHITE SUBSTANCE AND A HARSH ODOR. SHE STOPPED PUMPING AT THAT TIME. SHE CONTACTED THE MFR, WHO INSTRUCTED HER TO RETURN THE BAGS IN THE BOX TO THEM. STATED THEY WOULD CHECK THE SUBSTANCE TO SEE IF HARMFUL. IN 2009, RPTR SENT THE PRODUCT OVERNIGHT EXPRESS WITH A RMA NUMBER TO TRACK. PRODUCT REC'D BY MFR THE NEXT DAY. APPROX TWO MONTHS LATER, MFR CONTACTED RPTR, STATING WOULD LOOK INTO THE PROBLEM AND GET BACK TO HER. MFR CALLED RPTR 1-2X / WEEK; STATED NOT LOGGED IN YET, NOT SURE WHERE PRODUCT WAS, WAS MISPLACED, RMA NUMBER MISLOCATED, ETC. ON 4-23-09, MFR SAID THEY COULDN'T FIND PRODUCT, AND SINCE PT WAS OK, NOT TO WORRY ABOUT IT. RPTR IS VERY WORRIED. A WEEK LATER, MFR INFORMED RPTR THE PRODUCT WAS APPARENTLY THROWN IN THE TRASH AND THAT WAS WHY THEY COULDN'T FIND IT. RPTR STILL HAS ONE SAMPLE BAG AND IS REQUESTING HELP FROM FDA TO FIND OUT IF CHILD COULD HAVE BEEN HARMED.

    Description of Event or Problem · 1

    I AM A NEW MOTHER, BREAST-FEEDING MY FIRST CHILD & USING MEDELA, INC. BREAST PUMP AND ASSOCIATED PRODUCTS. I PURCHASED MEDELA, INC. 50CT. "PUMP & SAVE" BREASTMILK STORAGE BAGS FROM BABIES "R" US. I BEGAN USING THE BAGS ON A DAILY BASIS IN 2009, TO STORE QUANTITIES OF MILK FOR USE AT A LATER DATE. AFTER USING APPROX 30 BAGS FROM THE BOX, I REMOVED A SECTION OF BAGS FROM THE SEALED CONTAINER THAT WERE STUCK TOGETHER BY AN UNKNOWN WHITE SUBSTANCE WITH A HARSH NOXIOUS ODOR. I PROMPTLY CONTACTED MEDELA, INC. TO REPORT THE PROBLEM WITH THE PRODUCT & REQUEST THAT THE CONTAMINATED BAGS BE LOOKED AT TO DETERMINE WHAT THE UNKNOWN CONTAMINATE WAS. I WAS INSTRUCTED TO RETURN THE AFFECTED BAGS & THE BOX CONTAINING THE LOT# TO THEIR CORPORATE HEADQUARTERS, FOR TESTING. TWO MONTHS LATER, I EXPRESS MAILED THE CONTAMINATED PRODUCTS TO THEIR LOCATION AS DIRECTED, USING THE -RMA# I WAS INSTRUCTED TO LABEL THE INFO WITH -RMA#-. I RECEIVED NOTIFICATION VIA EMAIL THAT THE PACKAGE WAS SIGNED FOR BY REP OF MEDELA, INC, ON APRIL 3, 2009. ON APRIL 6TH I CONTACTED MEDELA, INC TO CHECK ON THE STATUS OF MY RMA AND TO DETERMINE HOW LONG IT WOULD BE BEFORE I WOULD HEAR BACK ON THE FINAL DETERMINATION OF THEIR TESTING ON MY AFFECTED BAGS. AT THAT TIME I TOUCHED BASE WITH QUALITY CONTROL MANAGER. HE ADVISED THAT HE WOULD BE PERSONALLY LOOKING INTO THE RMA AND REPORTING BACK THE FINDINGS TO ME AS SOON AS POSSIBLE. SINCE THAT DATE, QC MANAGER HAS CONTACTED ME 4-5 TIMES OVER THE COURSE OF THE 3 WEEKS THAT FOLLOWED TO ADVISE THAT MY RMA HAD NOT BEEN LOGGED IN YET, MY RMA MAY HAVE BEEN MISPLACED, MY RMA COULD NOT BE LOCATED. SEVENTEEN DAYS LATER, QC MANAGER CONTACTED ME TO ADVISE THAT MY RMA HAS NOT BEEN LOCATED AND THAT HE "TRUSTS THAT MY CHILD IS OKAY, AND NOT TO WORRY ABOUT THE AFFECTED PRODUCTS." I HAVE RETAINED A SAMPLE OF THE AFFECTED BAGS FOR MY OWN PROTECTION AND WOULD LIKE TO HAVE THIS ISSUE LOOKED INTO FURTHER BY THE FDA. I GREATLY APPRECIATE BEING CONTACTED BY A REP TO DISCUSS HOW TO PROGRESS WITH THE REMAINING SAMPLE BAGS I HAVE AND TO DETERMINE HOW BEST TO HANDLE THIS SO THAT I CAN DETERMINE WHAT THE UNKNOWN SUBSTANCE IS ON THE BAGS; TO FIND OUT WHETHER THE SUBSTANCE IS HARMFUL TO MY NEWBORN SON. I CAN BE CONTACTED FOR FURTHER INFORMATION. DATES OF USE: 2009. DIAGNOSIS OR REASON FOR USE: STORAGE OF BREAST MILK FOR FEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDELA PUMP AND SAVE BREAST PUMP BAGS BREAST PUMP BAGS HGY MEDELA, INC. 45028A 82892

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other