BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 7135919 · Received December 20, 2017

    Report

    Report Number
    9610847-2017-00196
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 28, 2017
    Report Date
    January 29, 2018
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    K923702
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BD RECEIVED TWO (2) REPRESENTATIVE UNITS FOR EVALUATION FROM THE CUSTOMER IN SUPPORT OF THIS COMPLAINT. OUR QUALITY ENGINEER VISUALLY INSPECTED THE RETURNED UNITS AND WAS UNABLE TO IDENTIFY ANY DAMAGE TO ANY OF THE UNITS' COMPONENTS. LEAK TESTING WAS THEN PERFORMED AND NO LEAKAGE WAS OBSERVED THROUGHOUT THE DEVICES. WE WERE UNABLE TO DETERMINE A ROOT CAUSE FOR THIS OCCURRENCE BASED ON THE PROVIDED SAMPLES. BD WAS UNABLE TO CONFIRM THE REPORTED DEFECT BY CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7083688, MEDICAL DEVICE EXPIRATION DATE: 2021-03-31, DEVICE MANUFACTURE DATE: 2017-04-26, MEDICAL DEVICE LOT #: 7083688, MEDICAL DEVICE EXPIRATION DATE: 2020-09-30, DEVICE MANUFACTURE DATE: 2016-09-14.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF A BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM, IT WAS FOUND LEAKING. THE ¿CATHETERS SEEM TO HAVE A HOLE OR TO BE CUT.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    916045 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other