BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL¿ LUER-LOCK INJECTOR

    MDR report key: 16902458 · Received May 10, 2023

    Report

    Report Number
    3003152976-2023-00170
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    April 12, 2023
    Report Date
    June 30, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 30-JUN-2023. H6: INVESTIGATION SUMMARY: SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION OF THE INJECTOR, NO DEFECTS OR ISSUES OBSERVED. THE INJECTOR WAS CONNECTED TO A BD SYRINGE LOADED WITH DECONTAMINATION LIQUID, AND THE INJECTOR WAS CONNECTED TO A C45 (TESTS) AND THE LIQUID WAS TRANSFERRED BETWEEN ALL THE COMPONENTS WITHOUT OBSERVING ANY LEAKAGE BETWEEN ANY OF THE COMPONENTS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2203033, 2211161 NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF THE SAME LOT WERE USED FOR ADDITIONAL EVALUATION. NO DEFECTS OR ISSUES OBSERVED. FUNCTIONAL TESTING WAS PERFORMED, CONNECTING THE INJECTOR SAMPLES TO A VIAL, AND SYRINGE PER THE INSTRUCTIONS FOR USE PROVIDED WITH THE PRODUCT. IN ALL CASES LIQUID WAS ABLE TO BE DRAWN FROM THE INJECTOR AND THE PRODUCT FUNCTIONED AS INTENDED WITH NO LEAKAGE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE, INCLUDING VERIFICATION ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION AND THERE IS NO DAMAGE ON THE PRODUCT. TESTING RESULTS WERE REVIEWED FOR THE REPORTED LOT AND FOUND ALL PRODUCT MET REQUIRED SPECIFICATIONS. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHILE USING BD PHASEAL¿ LUER-LOCK INJECTOR LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT LEAKAGE DURING THE USE OF BD PHASEAL¿ LUER-LOCK INJECTOR. THE CUSTOMER REPORTED THAT SALINE LEAKING FROM THE INJECTOR WAS OBSERVED UPON PRIMING OF SALINE. D1: MEDICAL DEVICE BRAND NAME: BD PHASEAL¿ LUER-LOCK INJECTOR D2: MEDICAL DEVICE TYPE: ONB D4: UDI #: (B)(4) D4: MEDICAL DEVICE CATALOG #: 515086

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INFUSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT LEAKAGE DURING THE USE OF 515540-ZAT. THE CUSTOMER REPORTED THAT SALINE LEAKING FROM THE INJECTOR WAS OBSERVED UPON PRIMING OF SALINE. 515505-ZAT(LOT:2212041C) USED WILL BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ LUER-LOCK INJECTOR LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT LEAKAGE DURING THE USE OF BD PHASEAL¿ LUER-LOCK INJECTOR. THE CUSTOMER REPORTED THAT SALINE LEAKING FROM THE INJECTOR WAS OBSERVED UPON PRIMING OF SALINE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PHASEAL¿ INFUSION SET LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT LEAKAGE DURING THE USE OF 515540-ZAT. THE CUSTOMER REPORTED THAT SALINE LEAKING FROM THE INJECTOR WAS OBSERVED UPON PRIMING OF SALINE. 515505-ZAT(LOT:2212041C) USED WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217101 BD PHASEAL¿ LUER-LOCK INJECTOR 515086 FPA BECTON DICKINSON, S.A. 2203003

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown