BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD MYPICC KIT POWRPICC SOLO FT SHERLOCK 3CG (5F) (DUAL-LUMEN) (TPS)

    MDR report key: 8177416 · Received December 18, 2018

    Report

    Report Number
    3006260740-2018-03604
    Event Type
    Malfunction
    Date Received
    December 18, 2018
    Report Date
    January 24, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741121241
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 OF OUTER PACKAGING BEING OPEN IS CONFIRMED BUT THE EXACT CAUSE COULD NOT BE DETERMINED. ONE BARD MYPICC KIT WAS RETURNED FOR INVESTIGATION WITH REF: CK000610 AND LOT: 18GBL521. THE OUTER BAG SEAL WAS OBSERVED TO BE PARTIALLY OPENED. THE OPENED AREA MEASURED TO BE 17 CM STARTING 8.8 CM FROM THE LEFT SIDE OF THE KIT. THE PRESENCE OF MATERIAL TRANSFER FROM THE SEAL MEASURED TO BE 1.2 CM IN THICKNESS AND WAS CONSISTENT ACROSS THE OPEN SECTION OF THE SEAL. THE POUCH WITHIN THE PACKAGE CONTAINING THE LIDOCAINE VIAL APPEARS TO BE DAMAGED SINCE FLUID WAS OBSERVED WITHIN THE PACKAGING. THE KIT APPEARS TO HAVE BEEN HANDLED WITH A LARGE FORCE THAT CAUSED A BREAK IN THE LIDOCAINE VIAL AND HEADER BAG SEAL. THE PACKAGING SHOWS EVIDENCE THAT IT WAS PROPERLY SEALED, BUT MUST HAVE BEEN INADVERTENTLY OPENED AND MAY HAVE OCCURRED OUTSIDE BD CONTROL DUE TO IMPROPER HANDLING OR STORAGE CONDITIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE KIT WAS OPENED ON THE SIDE SEAL UPON RECEIPT, OUT OF THE CASE.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF 18GBL521 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE KIT WAS OPENED ON THE SIDE SEAL UPON RECEIPT, OUT OF THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016835 BARD MYPICC KIT POWRPICC SOLO FT SHERLOCK 3CG (5F) (DUAL-LUMEN) (TPS) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS CK000610 18GBL521 00801741121241

    Patients

    Seq Age Sex Outcome Treatment
    1