BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL INJECTOR LUER LOCK N35J

    MDR report key: 9323727 · Received November 14, 2019

    Report

    Report Number
    3003152976-2019-00780
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 30, 2019
    Report Date
    March 31, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. FRAGMENTATION TESTING IS PERFORMED ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED BY THE INJECTOR WHEN MATED TO OTHER COMPONENTS AFTER TEN ACTIVATIONS. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. FUNCTIONAL TESTING WAS PERFORMED USING THREE RETAINED SAMPLES FROM INJECTOR SAMPLES FROM LOT 9323974 ALONG WITH THREE RETAINED PROTECTORS OF LOT 1905124. ALL PROTECTORS WERE CONNECTED TO THE VIAL USING THE M12 FIXTURE ASSEMBLY. THE INJECTOR AND SYRINGE WERE CONNECTED AND PUNCTURED THE PROTECTOR 10 TIMES. AFTER ALL TESTING WAS COMPLETED, NO FOREIGN MATTER WAS IDENTIFIED INSIDE THE SYRINGE OR VIAL, NO CORING HAD OCCURRED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35J THERE WAS AN ISSUE WITH CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CUSTOMER REQUESTED TO INVESTIGATE THE RATE OF OCCURRENCE OF CORING WITH P50 AND N35. PLEASE VERIFY THE CONNECTION OF P50 AND N35.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD PHASEAL¿ INJECTOR LUER LOCK N35J THERE WAS AN ISSUE WITH CORING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: CUSTOMER REQUESTED TO INVESTIGATE THE RATE OF OCCURRENCE OF CORING WITH P50 AND N35. PLEASE VERIFY THE CONNECTION OF P50 AND N35.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1114390 BD PHASEAL INJECTOR LUER LOCK N35J INJECTOR ONB BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other