BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.6F X 50CM DUAL VASCU-PICC

    MDR report key: 11813228 · Received May 12, 2021

    Report

    Report Number
    2518902-2021-00025
    Event Type
    Malfunction
    Date Received
    May 12, 2021
    Date of Event
    March 5, 2021
    Report Date
    May 20, 2021
    Manufacturer
    MEDICAL COMPONENTS, INC.
    Product Code
    LJS
    UDI-DI
    00884908146493
    PMA / PMN Number
    K102966
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE WAS RETURNED. A PHOTOGRAPH WAS PROVIDED SHOWING WHAT APPEARS TO BE A SLICE IN THE LUMEN, INDICATIVE OF BEING CUT WITH A SHARP INSTRUMENT. THE SLICE/CUT APPEARS TO BE AT AN ANGLE AND THROUGH APPROXIMATELY 3/4 OF THE LUMEN DIAMETER. AS THE LUMEN IS IMPLANTED FULLY IN THE PATIENT IT IS NOT EXPOSED TO SHARP OBJECTS. IT IS NOT KNOWN IF THE DEVICE WAS CHECKED FOR NICKS OR SMALL CUTS PRIOR TO INSERTION. THE CONTRACT MANUFACTURER CONDUCTED A REVIEW OF THE MANUFACTURE RECORDS FOR THE LOT NUMBER REPORTED. THEIR INVESTIGATION REVEALED THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATION WITH NO NON-CONFORMANCES OR ABNORMALITIES. THE DEVICE WAS INSPECTED ACCORDING TO SPECIFICATION AS WELL. THIS INSPECTION INCLUDED A 100% LEAK TEST OF THE DEVICE. THIS TEST WOULD HAVE DETECTED THE LEAK IF IT HAD OCCURRED DURING THE MANUFACTURE PROCESS. WITHOUT AN EVALUATION OF THE DEVICE A ROOT CAUSE CANNOT BE DETERMINED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    WE ARE AWAITING ADDITIONAL INFORMATION AND CLARIFICATION OF THE EVENT. OUR INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PLACED PICC. X-RAY OBTAINED. PULLED BACK CATHETER AND WAS UNABLE TO FLUSH. CATHETER REMOVED AND LINE FOUND TO BE CRACKED 2CM FROM TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710798 2.6F X 50CM DUAL VASCU-PICC VASCU-PICC LJS MEDICAL COMPONENTS, INC. MD17012601 MPFF010 00884908146493

    Patients

    Seq Age Sex Outcome Treatment
    1