BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM

    MDR report key: 8203612 · Received December 28, 2018

    Report

    Report Number
    9610847-2018-00455
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    December 12, 2018
    Report Date
    February 13, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBERS 7300684 & 3241753. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS EITHER BATCH OF SAF-T-INTIMA. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY THE PHOTOGRAPH THAT WAS SUBMITTED BY YOUR FACILITY DID NOT SUFFICIENTLY DISPLAY THE REPORTED FAILURE MODE FOR THE DETERMINATION OF THE ROOT CAUSE. UNFORTUNATELY THE AFFECTED SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM SAFETY SYSTEM DID NOT ACTIVATE AND THE NEEDLE REMAINED IN THE CATHETER. THIS CAUSED THE PATIENT TO BLEED AND THE CAREGIVER WAS EXPOSED TO THE PATIENTS BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7241753; MEDICAL DEVICE EXPIRATION DATE: 2021-08-31; DEVICE MANUFACTURE DATE: 2017-09-29. MEDICAL DEVICE LOT #: 7300684; MEDICAL DEVICE EXPIRATION DATE: 2021-10-31; DEVICE MANUFACTURE DATE: 2017-11-21. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM SAFETY SYSTEM DID NOT ACTIVATE AND THE NEEDLE REMAINED IN THE CATHETER. THIS CAUSED THE PATIENT TO BLEED AND THE CAREGIVER WAS EXPOSED TO THE PATIENTS BLOOD. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044167 BD SAF-T-INTIMA¿ INTEGRATED SAFETY CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other