BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL CONNECTOR LUER LOCK C35J

    MDR report key: 10512018 · Received September 9, 2020

    Report

    Report Number
    3003152976-2020-00403
    Event Type
    Malfunction
    Date Received
    September 9, 2020
    Date of Event
    August 19, 2020
    Report Date
    January 11, 2021
    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

    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: 2020-11-19. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, NO DAMAGE OR DEFECTS WERE OBSERVED ON THE CONNECTOR OR RELATED TO THE MEMBRANE SEALING, IT WAS NOTED THE MEMBRANE HAD BEEN PUNCTURED. DIMENSIONAL TESTING WAS PERFORMED ON THE LUER THREAD, VERIFYING ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2001108, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED ISSUE FIVE RETAINED SAMPLES OF LOT 2001108 WERE USED FOR ADDITIONAL EVALUATIONS. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED, NO LEAKAGE OCCURRED AND ALL LUER DIMENSIONS WERE WITHIN REQUIRED SPECIFICATION. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL EVALUATIONS THROUGHOUT MANUFACTURING, INCLUDING LEAKAGE TESTING AND DIMENSIONAL VERIFICATIONS. RESULTS FOR THE REPORTED LOT WERE REVIEWED AND NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CALSED LEAKED FROM THE CONNECTION BETWEEN THE BD PHASEAL¿ CONNECTOR LUER LOCK C35J AND TERUMO CHEMOSAFE'S INFUSION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "THE CUSTOMER WAS USING C35J COMBINED WITH TERUMO CHEMOSAFE INFUSION SET. DURING INFUSION, THE ANTICANCER DRUG, CALSED LEAKED FROM THEIR CONNECTION."

    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 CALSED LEAKED FROM THE CONNECTION BETWEEN THE BD PHASEAL¿ CONNECTOR LUER LOCK C35J AND TERUMO CHEMOSAFE'S INFUSION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER WAS USING C35J COMBINED WITH TERUMO CHEMOSAFE INFUSION SET. DURING INFUSION, THE ANTICANCER DRUG, CALSED LEAKED FROM THEIR CONNECTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976879 BD PHASEAL CONNECTOR LUER LOCK C35J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2001108

    Patients

    Seq Age Sex Outcome Treatment
    1 Other