BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS

    MDR report key: 7040656 · Received November 17, 2017

    Report

    Report Number
    1018233-2017-05954
    Event Type
    Malfunction
    Date Received
    November 17, 2017
    Report Date
    January 31, 2018
    Manufacturer
    BARD BRACHYTHERAPY, INC. -1424526
    Product Code
    KXK
    PMA / PMN Number
    K043246
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE LABELING, PRODUCT CERTIFICATE, AND 10% ASSAY CERTIFICATE INCLUDED THE INCORRECT IMPLANT DATE. THE CORRECT IMPLANT DATE WAS (B)(6) 2017; HOWEVER, THE LABELING AND PRODUCT CERTIFICATES HAD AN IMPLANT DATE LISTED AS (B)(6) 2017. IN ADDITION, DURING THE REVIEW OF THE BARD BRACHYTHERAPY LABELING AND CUSTOMER ORDER RELEASE DOCUMENTATION, IT WAS ALSO NOTICED THAT THE SEED REFERENCE DATE WAS ALSO INCORRECT AND WAS LISTED AS (B)(6) 2017. THE LABELING WAS FOUND TO BE INADEQUATE. (B)(4). THE DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY RECEIVED THE CORRECT ORDER OF SEEDS WITH THE INCORRECT IMPLANT DATE. THE ORIGINAL ORDER WAS RECEIVED AND PROCESSED ON (B)(6) 2017 TO HAVE AN IMPLANT DATE OF (B)(6) 2017 WITH A SEED REFERENCE DATE OF (B)(6) 2017. ON (B)(6) 2017, A REVISION REQUEST FOR THIS ORDER WAS RECEIVED FROM THE CUSTOMER AND THE IMPLANT DATE WAS CHANGED TO (B)(6) 2017 WITH THE REFERENCE DATE OF (B)(6) 2017, PER THE CUSTOMER¿S REQUEST. THE NEW ORDER WAS PRINTED ON (B)(6) 2017 WHICH REFLECTED THE REVISED DATES. HOWEVER; THE ORDER THAT WAS FILLED AND SHIPPED TO THE CUSTOMER HAD THE ORIGINAL (INCORRECT) DATES ON THE ASSAY CERT AND LABELS. THE PATIENT RECEIVED ALL THE SEEDS AS PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY RECEIVED THE CORRECT ORDER OF SEEDS WITH THE INCORRECT IMPLANT DATE. THE ORIGINAL ORDER WAS RECEIVED AND PROCESSED ON (B)(6) 2017 TO HAVE AN IMPLANT DATE OF (B)(6) 2017 WITH A SEED REFERENCE DATE OF (B)(6) 2017. ON (B)(6) 2017, A REVISION REQUEST FOR THIS ORDER WAS RECEIVED FROM THE CUSTOMER AND THE IMPLANT DATE WAS CHANGED TO (B)(6) 2017 WITH THE REFERENCE DATE OF (B)(6) 2017, PER THE CUSTOMER¿S REQUEST. THE NEW ORDER WAS PRINTED ON (B)(6) 2017 WHICH REFLECTED THE REVISED DATES. HOWEVER; THE ORDER THAT WAS FILLED AND SHIPPED TO THE CUSTOMER HAD THE ORIGINAL (INCORRECT) DATES ON THE ASSAY CERT AND LABELS. THE PATIENT RECEIVED ALL THE SEEDS AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820719 BARD® QUICKLINK¿ CARTRIDGES WITH BRACHYSOURCE® I-125 SEEDS BRACHY SEEDS KXK BARD BRACHYTHERAPY, INC. -1424526 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1