BEUDAMED
    FDA Adverse Event Other Summary report: N

    SUPPORT CATHETER

    MDR report key: 2987546 · Received February 26, 2013

    Report

    Report Number
    2020394-2013-10001
    Event Type
    Other
    Date Received
    February 26, 2013
    Report Date
    February 19, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MEDWATCH IS NOT ASSOCIATED WITH A CUSTOMER COMPLAINT OR REPORTED ADVERSE EVENT; HOWEVER, IT IS BEING FILED IN ACCORDANCE WITH 21CFR PART 803.53. THE INITIAL MEDICAL ASSESSMENT HAS INDICATED THERE COULD BE AN IMMEDIATE INCREMENTAL RISK TO PTS WHO HAVE HAD A PROCEDURE PERFORMED WITH THE AFFECTED CODE/LOT NUMBERS LISTED BELOW: PRODUCT CODE: (B)(4), LOT NUMBER: FCWC10010; PRODUCT CODE: (B)(4), LOT NUMBER: FCWC10009. THE MFR HAS ISSUED A RECALL NOTIFICATION TO THE IDENTIFIED CUSTOMERS WHO HAVE RECEIVED THE AFFECTED PRODUCTS. ON (B)(4) 2013, THE MFR NOTIFIED THE FDA (B)(4) RECALL COORD OF THE PENDING VOLUNTARY RECALL AND GAINED CONCURRENCE OF THE CUSTOMER NOTIFICATION LETTER PRIOR TO ITS DISTRIBUTION. ON (B)(4) 2013, THE VOLUNTARY RECALL WAS INITIATED.

    Description of Event or Problem · 1

    BARD PERIPHERAL VASCULAR (BPV) HAS CONFIRMED THAT ONE LOT EACH OF TWO PRODUCT CODE NUMBERS WERE INADVERTENTLY SHIPPED TO CUSTOMERS AS NON-STERILE (WITHOUT STERILIZATION). THE ISSUE WAS DISCOVERED DURING A REVIEW OF INTERNAL PROCESSES ASSOCIATED WITH THE SUPPORT CATHETERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83251 SUPPORT CATHETER DQY BARD PERIPHERAL VASCULAR, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1