BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILE DRAPE SLEEVES

    MDR report key: 4080917 · Received August 28, 2014

    Report

    Report Number
    3005677147-2014-00008
    Event Type
    Malfunction
    Date Received
    August 28, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 27, 2014
    Manufacturer
    FHC, INC.
    Product Code
    MMP
    PMA / PMN Number
    K011992
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DESPITE SEVERAL ATTEMPTS TO CONTACT THE CUSTOMER, FHC HAS HAD NO REPLY COMMUNICATION REGARDING THE STATUS OF THE WITH PRODUCT. ALL UNOPENED RETURNED BOXES WERE RELABELED WITH THE CORRECT EXPIRATION DATE. OPENED BOXES OF PRODUCT WERE DESTROYED.

    Description of Event or Problem · 1

    AN EXPIRATION DATE DISCREPANCY OF STERILE DRAPE SLEEVES, MODEL E5-81, LOT 150117, WAS FOUND DURING AN INTERNAL AUDIT. VENDOR PAPER WORK SHOWS AN EXPIRATION DATE OF FEBRUARY 2018. THE INTERNAL INVENTORY AND SALES SYSTEM SHOWS AN EXPIRATION DATE OF MAY 4, 2017. PRODUCTS MADE FROM THIS LOT SHOW AN EXPIRATION DATE OF MAY 4, 2018. (B)(4) PRODUCTS WERE MADE (CATALOG #66-DA-SD AND FC1004). (B)(4) UNITS WERE SHIPPED TO (B)(4) DIFFERENT CUSTOMERS (PACKAGED 20 UNITS TO A BOX). A PRODUCT HOLD WAS IMMEDIATELY PLACED ON THE REMAINING INTERNAL STOCK, WHICH WAS RELABELED WITH THE CORRECT FEBRUARY 1, 2018 EXPIRATION DATE. THEREFORE, THE (B)(4) CUSTOMERS WHO HAD PURCHASED THE PRODUCT WERE CONTACTED VIA PHONE OR PERSONAL VISIT ON (B)(6) 2014 TO ISSUE A MARKET WITHDRAWAL. THE COMMUNICATION WAS FOLLOWED-UP WITH A FORMAL MARKET WITHDRAWAL LETTER. A PROCESS CHANGE WAS IMPLEMENTED AND WILL BE TESTED WITH THE NEXT VENDOR SHIPMENT OF E5-81 DRAPE SLEEVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523733 STERILE DRAPE SLEEVES STERILE DRAPE SLEEVES MMP FHC, INC. E5-81 150117

    Patients

    Seq Age Sex Outcome Treatment
    1