BEUDAMED
    FDA Adverse Event Injury Summary report: N

    24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER

    MDR report key: 6603047 · Received May 31, 2017

    Report

    Report Number
    8041187-2017-00047
    Event Type
    Injury
    Date Received
    May 31, 2017
    Date of Event
    May 9, 2017
    Report Date
    June 23, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. HOWEVER, THE MANUFACTURING SITE IN (B)(4) HAS COMPLETED A NO SAMPLE INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6053177. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. AN ABSOLUTE ROOT CAUSE CANNOT YET BE DETERMINED AS THE DEVICE EVALUATION ON THE AVAILABLE SAMPLE HAS NIT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE IN OPENED PACKAGING, AND ONE UNUSED SAMPLE IN A CLOSED PACKAGING WAS RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE USED UNIT SHOWED A KINKED CATHETER. THE ACTUAL SAMPLE ALSO PASSED A LEAK TEST. A VISUAL INSPECTION OF THE OF THE UNUSED SAMPLE SHOWED NO ABNORMALITIES. A DEVICE HISTORY RECORD SHOWED NO QUALITY NOTIFICATIONS WITH THIS BATCH. A MANUFACTURING REVIEW SHOWED NO ABNORMALITIES. CONCLUSION: THE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. THE CATHETER WAS KINKED ON THE CATHETER TUBING BUT PASSED THE CATHETER LEAK TEST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO A CRACK AND KINK IN A 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER CAUSED A LEAKAGE, AND THE PATIENT WAS SWITCHED FROM IV ANTIBIOTICS TO ORAL ANTIBIOTICS. THERE WAS NO REPORT OF HARM OR ADDITIONAL MEDICAL INTERVENTIONS PROVIDED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383879 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 6053177

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention