BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL INJECTOR LUER LOCK N35J

    MDR report key: 11378177 · Received February 25, 2021

    Report

    Report Number
    3003152976-2021-00109
    Event Type
    Malfunction
    Date Received
    February 25, 2021
    Date of Event
    January 28, 2021
    Report Date
    May 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: 2021-04-01. H6: INVESTIGATION SUMMARY: ONE INJECTOR SAMPLE ALONG WITH ONE SYRINGE, CONNECTOR, AND INFUSION BAG WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED WITH NO DEFECTS OBSERVED. THE SAMPLES WERE FUNCTIONALLY TESTED, IN ALL CASES LIQUID WAS ABLE TO MOVE THROUGH THE CONNECTOR AND INTO THE INFUSION BAG WITHOUT ISSUE, THERE WAS NO EVIDENCE OF RESISTANCE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003113, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. PRODUCT UNDERGOES A SERIES OF INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING FLOW RATE VERIFICATION. ALL RECORDS WERE REVIEWED FOR THE REPORTED LOT AND RESULTS WERE FOUND TO BE ACCEPTABLE. BASED ON THE SAMPLE EVALUATION AND OUR QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PHASEAL¿ INJECTOR LUER LOCK N35J HAD FLOW ISSUES WHILE ATTEMPTING TO PRIME IT DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "AFTER CONNECTING C100J, AN INFUSION SET, AND N35 (COMPLAINT PRODUCT), THE HCP ATTEMPTED PRIMING BUT FLUIDS DIDN'T FLOW. WHEN USING A NEW N35, FLUIDS FLOWED WITH NO PROBLEM. CLOGGING MAY BE OCCURRING IN THE COMPLAINT PRODUCT (N35). THE DRUG USED IS ENDOXAN."

    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 THE BD PHASEAL¿ INJECTOR LUER LOCK N35J HAD FLOW ISSUES WHILE ATTEMPTING TO PRIME IT DURING THE INFUSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AFTER CONNECTING C100J, AN INFUSION SET, AND N35 (COMPLAINT PRODUCT), THE HCP ATTEMPTED PRIMING BUT FLUIDS DIDN'T FLOW. WHEN USING A NEW N35, FLUIDS FLOWED WITH NO PROBLEM. CLOGGING MAY BE OCCURRING IN THE COMPLAINT PRODUCT (N35). THE DRUG USED IS ENDOXAN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276541 BD PHASEAL INJECTOR LUER LOCK N35J INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 2003113

    Patients

    Seq Age Sex Outcome Treatment
    1