BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    YUEH CENTESIS DISPOSABLE CATHETER NEEDLE

    MDR report key: 6577782 · Received May 19, 2017

    Report

    Report Number
    1820334-2017-01223
    Event Type
    Malfunction
    Date Received
    May 19, 2017
    Date of Event
    March 10, 2017
    Report Date
    May 19, 2017
    Manufacturer
    COOK INC
    Product Code
    GCB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF DOCUMENTATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL DATA, DRAWING, AND AN INSPECTION OF THE UNUSED PRODUCT WAS CONDUCTED DURING THE INVESTIGATION. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT WOULD CONTRIBUTE TO THIS FAILURE MODE. THERE WAS ONE OTHER REPORTED COMPLAINT FOR THIS LOT NUMBER. THE DEVICE IS SHIPPED WITH A 5FR PIGTAIL STRAIGHTENER (RM3505) AND EVERY DEVICE IS SHIPPED WITH AN IFU LABEL L_PAN_REV1 THAT ILLUSTRATES THAT THE PIGTAIL STRAIGHTENER SHOULD BE USED PRIOR TO INSERTION OF THE NEEDLE. INVESTIGATION OF THE DEVICE NOTED A PUNCTURE IN THE CATHETER, MEASURING APPROXIMATELY 3.9CM FROM THE DISTAL TIP. INVESTIGATION OF FIVE ADDITIONAL UNOPENED YUEH CENTESIS DISPOSABLE CATHETER NEEDLES, CONSISTING OF TWO SEPARATE LOT NUMBERS (NS7716126 AND NS7684398), WERE EXAMINED. TABLETOP TESTING VERIFIED THAT ADVANCEMENT OF THE NEEDLE ASSEMBLY THROUGH THE LUMEN OF THE CATHETER, UTILIZING THE SUPPLIED PIGTAIL STRAIGHTENER, ENCOUNTERED NO DIFFICULTY. FURTHER EXAMINATION CONFIRMED A SMOOTH TRANSITION OF NEEDLE CANNULA AND DISTAL TIP OF CATHETER. IT IS POSSIBLE THAT THE SUPPLIED PIGTAIL STRAIGHTENER WAS NOT USED PRIOR TO INSERTING THE NEEDLE, CAUSING THE NEEDLE TO SNAG ON THE CATHETER AND PUNCTURING THE DISTAL TIP AS MORE INSERTION FORCE WAS APPLIED. HOWEVER, BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    DEVICE CATALOG NUMBER: DTVN-5.0-19-10.0-YUEH-RDC-070896. (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

    CUSTOMER REPORTED THAT THE YUEH CENTESIS NEEDLE TIP IS PUNCTURING THE DISTAL CATHETER TIP. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATING TO THIS EVENT. THE DEVICE WAS RECEIVED FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359259 YUEH CENTESIS DISPOSABLE CATHETER NEEDLE GCB NEEDLE, CATHETER GCB COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1