BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    MDR report key: 1638962 · Received March 18, 2010

    Report

    Report Number
    9611451-2010-00150
    Event Type
    Other
    Date Received
    March 18, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE DISTRIBUTOR REPORTED THAT A BOX OF RT114 BREATHING CIRCUITS WAS LABELED WITH THE INCORRECT PRODUCT LABEL (RT203). THE PRODUCT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE IN (B)(4) WHO HANDLED THE PRODUCT DISPOSITION PER THE RELEVANT COMPANY PROCEDURES. AN IMAGE OF THE LABEL ON THE CIRCUIT BOX WAS PROVIDED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR ANALYSIS. RESULTS: THE IMAGE PROVIDED SHOWS AN RT203 PRODUCT LABEL. FISHER & PAYKEL HEALTHCARE'S REGIONAL OFFICE IN (B)(4) CONFIRMED THAT THE PACKAGE CONTAINED RT114 BREATHING CIRCUITS WITH LOT NUMBER 100112. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100112. CONCLUSION: THE PACKAGING HAD BEEN PRE-LABELED WITH AN RT203 PRODUCT LABEL, HOWEVER, THE MFG LINE CHANGED OVER TO THE RT114 BREATHING CIRCUIT. THIS RESULTED IN THE RT114 BREATHING CIRCUIT KITS BEING PACKED IN A BOX LABELED RT203. THERE ARE STANDARD OPERATING PROCEDURES (SOPS) IN PLACE TO ASSIST OPERATORS ON THE PRODUCTION LINE CORRECTLY PACK BREATHING CIRCUITS. THIS INCLUDES INSTRUCTIONS STATING THAT A LABEL SHOULD ONLY BE AFFIXED TO A BOX IF THE BOX IS GOING TO BE PACKED. (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THEY RECEIVED A BOX OF RT114 ADULT INSPIRATORY HEATED BREATHING CIRCUITS WITH AN RT203 PRODUCT LABEL. THE MISLABELED PACKAGE WAS DISCOVERED BY THE DISTRIBUTOR PRIOR TO CUSTOMER DISTRIBUTION OR PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT INSPIRATORY HEATED BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT114 100112

    Patients

    Seq Age Sex Outcome Treatment
    1