BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 5231402 · Received November 17, 2015

    Report

    Report Number
    3006948883-2015-00006
    Event Type
    Injury
    Date Received
    November 17, 2015
    Date of Event
    November 9, 2015
    Report Date
    December 3, 2015
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K100775
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION SHOWED A BREAK IN THE MIDDLE OF THE CATHETER. A MICROSCOPIC ANALYSIS REVEALED THAT THE AREA WHERE THE CATHETER HAD BROKEN WAS JAGGED AND THIN WITH A V-SHAPED CUT WHICH IS CHARACTERISTIC OF A NEEDLE PIERCING THROUGH THE CATHETER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 5012187. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, OUR QUALITY ENGINEER NOTES THAT THE MICROSCOPIC FINDINGS SUGGEST THAT THE CATHETER WAS SPEARED THROUGH BY A RE-CANNULATION AND THEN BROKE WHEN IT WAS WITHDRAWN.

    Additional Manufacturer Narrative · 1

    THE NAME OF THE INITIAL REPORTER IS UNKNOWN. THE REPORT WAS MADE BY THE (B)(6) AT (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A "DEMO PRACTICE" WITH BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, THE NURSE INSERTED THE CATHETER, SAW A FLASHBACK, AND THEN REMOVED THE IV. THE NURSE NOTED THAT UPON REMOVAL SHE OBSERVED THE INSERTION POINT TO BE ABNORMAL AND FOUND THE CATHETER HAD BROKEN. THE NURSE ALSO REPORTED THAT NO IV REINSERTION WAS PERFORMED. THE CATHETER WAS NOT FOUND OUTSIDE OF THE PATIENT SO THE NURSE THOUGHT THE BROKEN CATHETER REMAINED INSIDE THE PATIENT'S VEIN. THE PATIENT RECEIVED AN X-RAY ON (B)(6) 2015 BUT THE BROKEN CATHETER WAS NOT VISUALIZED. NO FURTHER MEDICAL INTERVENTIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759907 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 5012187

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention