BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTIMA II¿ IV CATHETER 24 G X 0.75 IN.

    MDR report key: 6335900 · Received February 16, 2017

    Report

    Report Number
    3006948883-2017-00004
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    January 19, 2017
    Report Date
    January 25, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICE LOT # AND MEDICAL DEVICE EXPIRATION DATE; DEVICE MANUFACTURE DATE: THE EXACT DEVICE USED IN THIS INCIDENT IS UNKNOWN. THE TWO FOLLOWING POTENTIAL LOT NUMBERS WERE PROVIDED: LOT 6204281, MEDICAL DEVICE EXPIRATION DATE 07/31/2019, DEVICE MANUFACTURE DATE 08/25/2016, LOT 6230039, MEDICAL DEVICE EXPIRATION DATE 09/30/2019, DEVICE MANUFACTURE DATE 10/14/2016. DEVICE EVALUATION: RESULT: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED POTENTIAL LOT NUMBERS 6204281 AND 6230039. CONCLUSION - WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SENT HOME WITH THE SUSPECT DEVICE AFTER BEING AT THE HOSPITAL FOR PNEUMONIA. THE DEVICE WAS PLACED TO THE BACK OF THE HAND FOR INFUSION OF CEPHALOSPORINS AND NOTHING ABNORMAL WAS NOTED DURING INSERTION. AFTER THE SECOND DAY OF INFUSION, THE FAMILY OF THE PATIENT FOUND THE CATHETER BROKEN AFTER THE PATIENT REMOVED THE DEVICE AT HOME. AN X-RAY WAS PERFORMED ON THE PATIENT BUT NO BROKEN CATHETER WAS DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120282 BD INTIMA II¿ IV CATHETER 24 G X 0.75 IN. INTRAVASCULAR CATHETER FOZ BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Required Intervention