BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL CONNECTOR LUER LOCK (C35)

    MDR report key: 10656102 · Received October 9, 2020

    Report

    Report Number
    3003152976-2020-00439
    Event Type
    Malfunction
    Date Received
    October 9, 2020
    Date of Event
    September 10, 2020
    Report Date
    December 7, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905152000
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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: 2020-10-20. H6: INVESTIGATION SUMMARY TWO HUNDRED AND ELEVEN SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUALLY INSPECTING THE PRODUCT, BLACK PARTICLES WERE OBSERVED TO BE EMBEDDED WITHIN THE CONNECTOR BODY ON ALL SAMPLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2001115, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO EMBEDED PARTICLES WITHIN THE PRODUCT. FINAL PRODUCTS ARE SUBJECTED TO BOTH VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT MANUFACTURING AND MACHINES UNDERGO PROPER MAINTENANCE AND CLEARLY DEFINE CLEANING ACCORDING TO PROCEDURE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THE PARTICLES LIKELY GENERATED DURING THE MOLDING PROCESS AS A RESULT OF DIRT ACCUMULATING WITHIN THE INJECTION MACHINE, THEM BECOMING EMBEDDED WITHIN THE CONNECTOR AS OBSERVED ON THE RETURNED PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN 221 BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DEVICES BEFORE USE DURING AN INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "FOREIGN MATTER CONFIRMED DURING IN-PROCESS INSPECTION".

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND IN 221 BD PHASEAL¿ CONNECTOR LUER LOCK (C35) DEVICES BEFORE USE DURING AN INSPECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "FOREIGN MATTER CONFIRMED DURING IN-PROCESS INSPECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1123973 BD PHASEAL CONNECTOR LUER LOCK (C35) INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515200 2001115 30382905152000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other