BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F

    MDR report key: 15196860 · Received August 10, 2022

    Report

    Report Number
    3006260740-2022-03115
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 15, 2022
    Report Date
    October 18, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    UDI-DI
    00801741027369
    PMA / PMN Number
    K122899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, PHOTOS WERE PROVIDED FOR REVIEW. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 08/2023).

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: THE DEVICE HISTORY RECORDS HAVE BEEN REVIEWED AND THIS LOT MET ALL RELEASE CRITERIA. THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: ONE PARTIALLY UNSEALED POWERPORT MRI CLEARVUE ISP IMPLANTABLE PORT KIT WAS RETURNED FOR EVALUATION. GROSS VISUAL EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. IN ADDITION TO THE RETURNED PHYSICAL SAMPLE, TWO ELECTRONIC PHOTOS WERE PROVIDED FOR REVIEW. DURING VISUAL EVALUATION, THE COMPONENTS TRAY WAS RECEIVED SEALED AND THE DEVICE COMPONENTS APPEARED UNAFFECTED. THE INVESTIGATION IS CONFIRMED FOR THE REPORTED TEAR, RIP OR HOLE IN DEVICE PACKAGING ISSUE AS A LONGITUDINAL CUT, WAS NOTED ON THE CENTER RIGHT OF BOTH THE TYVEK TRAY LABEL AND THE COMPONENTS TRAY LABEL. THE COMPONENTS TRAY WAS RECEIVED SEALED. THE DEVICE COMPONENTS APPEARED UNAFFECTED. FURTHER, THE PHOTO REVIEW ALSO CONFIRMS THE SAME. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON AVAILABLE INFORMATION. LABELING REVIEW: A REVIEW OF PRODUCT LABELING DOCUMENTATION (E.G. PROCEDURAL INSTRUCTIONS, INDICATIONS, WARNINGS, PRECAUTIONS, CAUTIONS, POSSIBLE COMPLICATIONS, CONTRAINDICATIONS, NURSING GUIDE, AND UNIT LABEL) DID NOT FIND ANY PRODUCT LABELING INADEQUACY. H10: D4 (EXPIRY DATE: 08/20230. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY OPENED AND NO LONGER VIABLE. THERE WAS NO PATIENT CONTACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO A PORT PLACEMENT PROCEDURE, THE PACKAGE WAS ALLEGEDLY OPENED AND NO LONGER VIABLE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1211065 POWERPORT CLEARVUE ISP IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 5608062 REGR0295 00801741027369

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown