BEUDAMED
    FDA Adverse Event Summary report: N

    IV3000 WINDOW FRAME 6X7CM

    MDR report key: 3772049 · Received April 25, 2014

    Report

    Report Number
    8043484-2014-00002
    Date Received
    April 25, 2014
    Date of Event
    March 21, 2012
    Report Date
    April 24, 2014
    Manufacturer
    SMITH AND NEPHEW MEDICAL LIMITED
    Product Code
    KGX
    PMA / PMN Number
    K895353
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED BY SMITH & NEPHEW AS A RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS, INCLUDING ADVERSE EVENTS, AS PART OF CORRECTIVE AND REMEDIATION ACTIONS FOLLOWING THE ISSUANCE OF THE 483 ISSUED NOVEMBER 26, 2013 TO SMITH & NEPHEW, INC (B)(4). SMITH & NEPHEW IS PERFORMING A TWO-YEAR RETROSPECTIVE REVIEW OF COMPLAINT FILES TO RE-ASSESS REPORTABILITY CRITERIA AND REPORTING DECISIONS MADE FOR COMPLAINTS RECORDED DURING THE TIME PERIOD UNDER REVIEW. THIS COMPLAINT HAS BEEN RE-ASSESSED IN ACCORDANCE UNDER THE PROVISIONS OF 21CFR 803.50 AND DEEMED REPORTABLE AS AN MDR. WE ARE SUBMITTING ONE (1) INITIAL, 30 DAY REPORT, MEDWATCH FDA FORM 3500A, FOR A PURPORTED DEVICE MALFUNCTION WHICH OCCURRED WHILE USING THE IV3000 1 HAND 6X7CM. THE INVESTIGATION INTO THIS COMPLAINT WAS LIMITED AS NO SAMPLES WERE RETURNED AND NO LOT INFORMATION PROVIDED. THE RESULTS OF THE INVESTIGATION WERE INCONCLUSIVE. ALL BATCHES ARE REQUIRED TO PASS ALL IN-PROCESS AND FINISHED PRODUCT TESTING PRIOR TO BEING RELEASED TO MARKET FOR SALE. AT THIS TIME, IT CANNOT BE CONCLUSIVELY DETERMINED IF THE PRODUCT WAS AT FAULT FOR THE LOOSE CANULA AND THEREFORE, NO CORRECTIVE ACTIONS WILL BE MADE TO THE PRODUCT OR PROCESS.

    Description of Event or Problem · 1

    LOW ADHESION PT STATES SHE HAD 3 INFUSION SETS FALL OFF BECAUSE THE IV 3000 DRESSING ADHESIVE WILL NOT STAY ADHERED TO SKIN. PT FIST USES THE DRESSING, THEN APPLIES SITE OVER DRESSING. LAST SITE INSERTED 2 HOURS BEFORE CALL, WHICH PT STATES IS STAYING ON WITH NO PROBLEM. PT STATES SHE WENT OUT TO BREAKFAST TO (B)(6) RESTAURANT THIS MORNING AND TOOK 8U TO COVER FOR HIGH CARB BREAKFAST. PT BG'S AT TIME OF CALL WERE 550MG/DL. PT DOES NOT CHECK FOR KETONES, DENIES N/V/SOB. PT TOOK 9U VIA PUMP AFTER CHECKING BG. PT DOES NOT USE INSULIN VIA INJECTIONS, DOES NOT HAVE SYRINGES. PT ONLY USES ABDOMEN FOR SITE INSERTION TIMES 8 YEARS. CONFIRMED ALL SETTINGS /HISTORY ARE CORRECT IN PUMP. HAD PT RETEST AFTER 20 MIN OF BOLUS AND BG WAS DOWN TO 349MG/DL. PT HAD CALLED (B)(4) WHERE SUPPLIES ARE PURCHASED AND WAITING FOR A CALL BACK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250955 IV3000 WINDOW FRAME 6X7CM TAPE AND BANDAGE, ADHESIVE KGX SMITH AND NEPHEW MEDICAL LIMITED 59410082

    Patients

    Seq Age Sex Outcome Treatment
    1