BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 6535785 · Received May 1, 2017

    Report

    Report Number
    8041187-2017-00040
    Event Type
    Injury
    Date Received
    May 1, 2017
    Date of Event
    April 11, 2017
    Report Date
    June 5, 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
    ND, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: SIX UNUSED SAMPLES IN SEALED PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF ALL UNITS REVEALED NO ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE POTENTIAL LOT NUMBERS 6141428, 6053154, 5354408, AND 6113190 REVEALED NO IRREGULARITIES DURING THE MANUFACTURING PROCESS. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER PROVIDED FOUR POTENTIAL LOT NUMBERS FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6141428, MEDICAL DEVICE EXPIRATION DATE: 5/31/2021, DEVICE MANUFACTURE DATE: 5/20/2016. MEDICAL DEVICE LOT #: 6053154, MEDICAL DEVICE EXPIRATION DATE: 2/28/2021, DEVICE MANUFACTURE DATE: 2/22/2016. MEDICAL DEVICE LOT #: 5354408, MEDICAL DEVICE EXPIRATION DATE: 12/31/2020, DEVICE MANUFACTURE DATE: 12/20/2015. MEDICAL DEVICE LOT #: 6113190, MEDICAL DEVICE EXPIRATION DATE: 4/30/2021, DEVICE MANUFACTURE DATE: 4/22/2016. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER BROKE OFF AT THE HUB WHILE IT WAS BEING REMOVED FROM A PATIENT (A DOG). THE DOG RECEIVED SEVERAL X-RAYS AND IT APPEARS THAT THE CATHETER IS STUCK IN THE DOG'S VEIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314772 24 G X .75 IN BD INSYTE¿ PERIPHERAL IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention