BEUDAMED
    FDA Adverse Event Summary report: N

    POWERWAND EXTENDED DWELL CATHETER

    MDR report key: 3886261 · Received June 10, 2014

    Report

    Report Number
    3009549229-2014-00001
    Date Received
    June 10, 2014
    Date of Event
    August 15, 2013
    Report Date
    June 5, 2014
    Manufacturer
    ACCESS SCIENTIFIC LLC
    Product Code
    DYB
    PMA / PMN Number
    K131300
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON DISCOVERY OF THE FACT THAT 160 POWERWAND DEVICES WERE BUILT WITHOUT PRODUCT LABELS OR DFUS AND THAT 30 OF THESE WERE SHIPPED TO 2 (TWO) CUSTOMERS. ACCESS SCIENTIFIC TOOK IMMEDIATE CORRECTIVE ACTION BY APPLYING THE APPROPRIATE PRODUCT LABELING TO THE DEVICES THAT WERE SHIPPED THE 2 CUSTOMERS (B)(4). FDA WAS NOTIFIED OF THIS FIELD CORRECTIVE ACTION TAKEN, REFER TO RECALL REPORT NO. Z-2254-2013 AND THE RECALL WAS TERMINATED BY FDA ON 09/24/2013. UNFORTUNATELY A COMPLAINT RECORD AND MDR WAS NOT FILED AT THE TIME OF THESE EVENTS. ACCESS SCIENTIFIC IS RETROSPECTIVELY FILING THIS MDR AS SOON AS THIS OVERSIGHT WAS BROUGHT TO OUR ATTENTION.

    Description of Event or Problem · 1

    THE FINISHED PRODUCT, POWERWAND EXTENDED DWELL CATHETER WAS SHIPPED TO AN ACCOUNT, (B)(6), WITHOUT PRODUCT LABELING OR DIRECTIONS FOR USE, DFUS. A TOTAL OF 20 DEVICES WERE SHIPPED TO THIS ACCOUNT. ANOTHER SHIPMENT OF 10 DEVICES WERE SHIPPED TO ANOTHER ACCOUNT, (B)(6) IN THE SAME CONDITION I.E. NO PRODUCT LABEL OR DFU. (B)(4). THE VASCULAR ACCESS PROFESSIONAL, NURSE OR PHYSICIAN COULD MISUSE THE DEVICE IN LIEU OF THE PRODUCT LABEL OR DFU AND MAY RESULT AN INJURY TO THE PT. THE USERS OF THE POWERWAND AT THESE TWO HOSPITALS HAVE BEEN COMPREHENSIVELY TRAINED IN THE PLACEMENT AND MAINTENANCE OF THE POWERWAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343407 POWERWAND EXTENDED DWELL CATHETER MIDLINE CATHETER DYB ACCESS SCIENTIFIC LLC 92006 I666473

    Patients

    Seq Age Sex Outcome Treatment
    1