BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F

    MDR report key: 14586673 · Received June 3, 2022

    Report

    Report Number
    3006260740-2022-02087
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 12, 2022
    Report Date
    November 5, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJT
    PMA / PMN Number
    K072549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATALOG NUMBER IDENTIFIED HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F ARE IDENTIFIED. AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE 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.

    Additional Manufacturer Narrative · 0

    H10: THE CATALOG NUMBER IDENTIFIED IN SECTION D4 HAS NOT BEEN CLEARED IN THE US BUT IS SIMILAR TO THE TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F THAT ARE CLEARED IN THE US. THE PRO CODE AND 510 K NUMBER FOR THE TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F ARE IDENTIFIED IN D2 AND G4. H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: ALTHOUGH THE PHYSICAL SAMPLE WAS NOT RETURNED FOR EVALUATION, SIX ELECTRONIC PHOTOS WERE PROVIDED FOR REVIEW. THE PHOTOS PIC 1.PNG & PIC 3.PNG SHOWS A LABEL VERIFICATION DATA USING A HIBC CODE. THE PHOTO PIC 2.PNG SHOWS A SUPPLIER BOM SHEET WHERE A SEARCH OF CATALOG (0605300CE) WAS FOUND MATCHES WITH THE TITANIUM PORT 8.0F CHRONO FLEX CATHETER. THE PHOTOS 3.PNG 2.PNG & 1.JPG SHOWS A CODE 39 BARCODE (+H3030605300CE0I). FOR FURTHER VERIFICATION, THE LABELING TEAM SCANNED THE PROVIDED THREE BARCODE PICTURES USING A HANDHELD SCANNER-SYMBOL TECH (PART NUMBER: LS4208-SR20007ZZR) AND DESKTOP SCANNER -WEBSCAN TRUCHECK OMNI BARCODE VERIFIER (PART NUMBER: MODEL NUMBER TC-833). HOWEVER, THE BARCODES WOULD NOT SCAN FROM ON-SCREEN IMAGES WITH BOTH HAND-HELD SCANNER AND DESKTOP SCANNER. HOWEVER, THE ORIGINAL LABELS WERE NOT RETURNED FOR EVALUATION AND ONLY THE PHOTOS OF THE BARCODES WERE PROVIDED FOR REVIEW WHICH CANNOT BE VERIFIED USING THE HANDHELD OR DESKTOP SCANNERS. BASED ON THE POOR SAMPLE CONDITION, THE INVESTIGATION IS INCONCLUSIVE FOR THE REPORTED INCORRECT BARCODE ISSUE. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE 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. 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. H3 OTHER TEXT: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD ISSUE WITH DEVICE MARKINGS AND LABELLING PROBLEM. THERE WAS NO REPORTED PATIENT INJURY,

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A PORT PLACEMENT PROCEDURE, THE DEVICE ALLEGEDLY HAD ISSUE WITH DEVICE MARKINGS AND LABELLING PROBLEM. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832551 TITANIUM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT C.R. BARD, INC. (BASD) -3006260740 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown