BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL OPTIMA INFUSION CLAMP M25-O

    MDR report key: 11823075 · Received May 13, 2021

    Report

    Report Number
    2243072-2021-01461
    Event Type
    Malfunction
    Date Received
    May 13, 2021
    Date of Event
    April 14, 2021
    Report Date
    June 24, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    KMK
    UDI-DI
    00382905150852
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-21. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, THE LATCH MECHANISM WAS OBSERVED TO BE BENT. A REVIEW OF LOT 2004106 WAS PERFORMED, ALL SAMPLES WERE 100% INSPECTED FOR PRODUCT FUNCTION AND NO DEVIATIONS WERE IDENTIFIED DURING THE MANUFACTURING OF THIS LOT THAT COULD CONTRIBUTE TO THE REPORTED FAILURE. TWENTY FIVE SAMPLES OF LOT 2004106 WERE USED FOR ADDITIONAL EVALUATION, ALL PRODUCT WAS INSPECTED AND NO SAMPLES WAS OBSERVED TO HAVE A BENT LOCKING MECHANISM. BASED ON OUR QUALITY TEAM'S INVESTIGATION, IT LIKELY THE LATCH BENT DUE TO FORCE APPLIED TO THE DEVICE WHILE IN THE INCORRECT POSITION. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD PHASEAL¿ OPTIMA INFUSION CLAMP M25-O THE CLAMPS ARE NOT SNAPPING CLOSED. THIS OCCURRED WITH 10 CLAMPS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MANY OF THE INFUSION CLAMPS ARE NOT SNAPPING CLOSE.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: (B)(4). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD PHASEAL¿ OPTIMA INFUSION CLAMP M25-O THE CLAMPS ARE NOT SNAPPING CLOSED. THIS OCCURRED WITH 10 CLAMPS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT MANY OF THE INFUSION CLAMPS ARE NOT SNAPPING CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719958 BD PHASEAL OPTIMA INFUSION CLAMP M25-O DEVICE, INTRAVASCULAR CATHETER SECUREMENT KMK BECTON DICKINSON 515085 2004106 00382905150852

    Patients

    Seq Age Sex Outcome Treatment
    1