BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MYPICC KIT

    MDR report key: 8331422 · Received February 12, 2019

    Report

    Report Number
    3006260740-2019-00237
    Event Type
    Malfunction
    Date Received
    February 12, 2019
    Report Date
    February 12, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741104251
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING WERE REVIEWED AS PART OF THIS INVESTIGATION: PATIENT SEVERITY, FREQUENCY ANALYSIS, APPLICABLE PREVIOUS INVESTIGATION(S), SAMPLE (IF AVAILABLE), APPLICABLE FMEA DOCUMENTS, LABELING, AND APPLICABLE MANUFACTURE RECORDS. BASED ON A REVIEW OF THIS INFORMATION, THE FOLLOWING WAS CONCLUDED: THE COMPLAINT THAT THE CUSTOMER RECEIVED EXPIRED PRODUCT WAS CONFIRMED AND A DATA RECORDING ERROR AT THE DISTRIBUTION CENTER APPEARED TO BE A CONTRIBUTING FACTOR IN THE REPORTED EVENT. ONE PHOTO OF A BARD MYPICC KIT LABEL WITH PRODUCT CODE CK000458 AND LOT 18NB2700 WAS PROVIDED FOR INVESTIGATION. THE EXPIRATION DATE ON THE LABEL WAS 2018-12-31. A REVIEW OF THE SALES ORDERS FOR THIS LOT SHOWED THAT TEN (10) UNITS WERE SHIPPED TO THE CUSTOMER AFTER THE EXPIRATION DATE ON THE LABEL. NO OTHER CUSTOMERS RECEIVED EXPIRED PRODUCT. IT WAS CONFIRMED THAT THE EXPIRATION DATE ON THE LABEL WAS CORRECT. THE EXPIRATION DATE WAS INCORRECTLY RECORDED IN THE SYSTEM AT THE DISTRIBUTION CENTER. SINCE THE EXPIRATION DATE IN THE SYSTEM HAD NOT BEEN SURPASSED AT THE TIME OF THE SHIPMENTS, EXPIRED PRODUCT WAS ALLOWED TO LEAVE THE DISTRIBUTION CENTER AFTER THE TRUE EXPIRATION DATE THAT WAS PRINTED ON THE UNIT LABEL. A LOT HISTORY REVIEW (LHR) OF 18NB2700 SHOWED NINE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE COMPLAINTS FOR THIS LOT NUMBER (18NB2700) HAVE BEEN REPORTED FROM THE SAME FACILITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TEN EXPIRED KITS WERE SENT TO THE FACILITY. IT WAS STATED THE PACKING SLIP HAD THE EXPIRATION DATE AS 12-31-2019 BUT PRINTED ON THE INDIVIDUAL KITS WAS THE DATE 12-31-18. THE KITS WERE NOT USED. THIS REPORT ADDRESSES THE NINTH KIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123101 BARD MYPICC KIT CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A 18NB2700 00801741104251

    Patients

    Seq Age Sex Outcome Treatment
    1