BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IV CATHETER

    MDR report key: 5364646 · Received January 13, 2016

    Report

    Report Number
    3006948883-2016-00002
    Event Type
    Injury
    Date Received
    January 13, 2016
    Date of Event
    December 25, 2015
    Report Date
    January 25, 2016
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE X-RAY(S) THE PATIENT RECEIVED WERE OF HIS/HER ARMS AND CHEST. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K) #: FOR BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THE 510(K) IS K100775. FOR BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER FOR THIS INCIDENT WAS NOT PROVIDED. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS A NURSE WAS CHECKING ON THE IV IN A PATIENT, THAT THE CATHETER WAS FOUND TO BE MISSING. THE HOSPITAL WAS UNABLE TO DETERMINE THE EXACT DEVICE THAT WAS USED BUT STATED THAT IT WAS EITHER A BD INTIMA-II "CLOSED IV CATHETER SYSTEM OR A BD PEGASUS "SAFETY CLOSED IV CATHETER SYSTEM. THE PATIENT RECEIVED AN X-RAY AND THE MISSING CATHETER WAS NOT FOUND WITHIN THE PATIENT. NO ADDITIONAL MEDICAL INTERVENTIONS WERE PROVIDED AND THE PATIENT LEFT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21741 UNKNOWN IV CATHETER INTRAVASCULAR CATHETER FOZ BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention