BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET

    MDR report key: 7130055 · Received December 19, 2017

    Report

    Report Number
    1820334-2017-04457
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Report Date
    March 27, 2018
    Manufacturer
    COOK INC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: REPORT SOURCE. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED PHOTOGRAPH OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PHOTOGRAPH OF THE DEVICE CONFIRMED THE PRESENCE OF A CRACK IN THE PICC LINE. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT LOT SEARCH COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE PHOTOGRAPH OF THE PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    510K #: K161496. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER WAS LEAKING. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NO INFORMATION HAS YET BEEN PROVIDED. THE CUSTOMER CONFIRMED THAT THE DEVICE WAS NOT SAVED; ACCORDINGLY, NO DEVICE WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    908183 SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET LJS TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER LJS COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1