BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ SPIKE CONNECTOR

    MDR report key: 15811316 · Received November 16, 2022

    Report

    Report Number
    3003152976-2022-00519
    Event Type
    Malfunction
    Date Received
    November 16, 2022
    Date of Event
    October 19, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 28-NOV-2022. H6: INVESTIGATION SUMMARY ONE SAMPLE AND MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED THAT THE SPIKE IS BROKEN, A PIECE OF THE SPIKE THREAD REMAINED STUCK ON THE CONNECTOR THREAD. TRACES OF THE SOLVENT USED TO BOND THE SPIKE TO THE CONNECTOR WERE OBSERVED. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING FORCE TESTING TO ENSURE PROPER ASSEMBLY OF THE DEVICE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201210, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. BASED ON THE SAMPLE EVALUATION IT WAS DETERMINED THE BREAKAGE LIKELY OCCURRED DURING USE, WHEN INSERTING THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR EXPERIENCED A BROKEN SPIKE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON ATTEMPT TO ENGAGE N35J WITH A SYRINGE, THE BONDING OF THE SPIKE AND C35J ON C180J WAS EASILY BROKEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ SPIKE CONNECTOR EXPERIENCED A BROKEN SPIKE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: UPON ATTEMPT TO ENGAGE N35J WITH A SYRINGE, THE BONDING OF THE SPIKE AND C35J ON C180J WAS EASILY BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375265 BD PHASEAL¿ SPIKE CONNECTOR INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2201210

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown