BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY GRAFT THROMBECTOMY CATHETER

    MDR report key: 1863415 · Received October 11, 2010

    Report

    Report Number
    2015691-2010-14188
    Event Type
    Malfunction
    Date Received
    October 11, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    MCW
    PMA / PMN Number
    K942457
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE CATHETER WAS RECEIVED IN A BROKEN SHIPPING TUBE. THE LIGHT PURPLE ADAPTOR IS BROKEN AT THE BOND SITE, WHERE IT IS BONDED TO THE WHITE SHIPPING TUBE. THE SHRINK SEALS ARE STILL ATTACHED, ONE AT THE ADAPTOR CAP AND THE OTHER AROUND THE DIRECTIONS FOR USE (DFU). ALTHOUGH THE REPORTED DEFECT WAS CONFIRMED, THERE IS NO EVIDENCE OF A MANUFACTURING NONCONFORMANCE. IT APPEARS THAT THE COMPROMISED PACKAGING TUBE OCCURRED SOMETIME AFTER PRODUCTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON BEHALF OF HER DAUGHTER (THE PATIENT) ALLEGING THAT THE PATIENT HAD ELEVATED BLOOD GLUCOSE LEVELS AND KETONES. THE REPORTER INDICATED THAT THE PATIENT RECEIVED A REPLACEMENT PUMP AND STARTED USING THE DEVICE THE EVENING BEFORE CONTACTING ANIMAS ON (B)(6), 2010. THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE WAS ALMOST 500 MG/DL THE NEXT MORNING. SHE FELT AS THOUGH THE BASAL INSULIN WAS NOT ABSORBING. THE ANIMAS CDE ASSISTED THE REPORTER WITH REVIEWING THE CORRECT SETTINGS BETWEEN THE PATIENT'S OLD PUMP AND THE NEW, REPLACEMENT PUMP. THE ANIMAS CDE ADVISED THE REPORTER TO CHANGE THE INSERTION SITES AND MONITOR THE PATIENT'S BLOOD GLUCOSE. THE ANIMAS CDE ALSO RECOMMENDED TO CHANGE THE INSERTION SITE WITH TWO BG LEVELS OVER 250 MG/DL OR ONE OVER 400 MG/DL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PACKAGE WAS RECEIVED THE TUBING APPEARED TO COME APART (PLASTIC CRACKED) AND LOOKED LIKE IT WAS TAPED AND "SHOVED" BACK IN THE PACKAGE. IT WAS BROKEN AT THE WHITE TO THE CLEAR PURPLE PLASTIC. THE OUTER BOX THAT THE DEVICE CAME IN WASN'T DAMAGED BUT IT LOOKED LIKE THE PLASTIC TUBE WAS TAPED. THE OUTER BOX (CARDBOARD) WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOGARTY GRAFT THROMBECTOMY CATHETER THROMBECTOMY CATHETER MCW EDWARDS LIFESCIENCES PR 160245F 58868940

    Patients

    Seq Age Sex Outcome Treatment
    1