BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL INJECTOR LUER LOCK N35C

    MDR report key: 10209790 · Received June 29, 2020

    Report

    Report Number
    3003152976-2020-00275
    Event Type
    Malfunction
    Date Received
    June 29, 2020
    Date of Event
    May 22, 2020
    Report Date
    September 10, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150044
    PMA / PMN Number
    K140591
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10 DEVICE AVAILABLE FOR EVALUATION? YES. D.10 RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION SUMMARY TWO SAMPLE INJECTORS AND SEVERAL PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGAITON. THROUGH VISUAL INSPECTION OF THE PHOTOS, SMALL WHITE PARTICLES CAN BE OBSERVED ON THE CANNULA. FURTHER EVALUATION OF THE DEVICE SHOWED THE SAFETY SLEEVE WAS REMOVED AND THE WINGS OF THE PISTON WERE DAMAGED. USING MAGNIFICATION, SMALL FRAGMENTS WERE VERIFIED TO BE ON THE CANNULA. NO FUNCTIONAL TESTING COULD BE PERFORMED DUE TO THE DAMAGE THAT WAS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2003101, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FRAGMENTATION TESTING IS PERFORMED DURING MANUFACTURING ACCORDING TO PROCEDURE, TO EVALUATE ANY PARTICULATES GENERATED BY THE INJECTOR WHEN MATED TO OTHER COMPONENTS AFTER TEN ACTIVATIONS. FRAGMENTATION TESTING WAS REVIEWED FOR LOT 2003101AND RESULTS WERE FOUND TO BE ACCEPTABLE. EIGHT RETAINED INJECTOR SAMPLES OF LOT 2003101WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS PERFORMED, PENETRATING THE INJECTOR WITH SAMPLE PROTECTORS FROM LOTS 2001121 AND 2002156. IN ALL CASES THE PRODUCT FUNCTIONED AS INTENDED AND NO CORING WAS IDENTIFIED. WHILE PHASEAL NEEDLES ARE DESIGNED TO REDUCE CORING, THERE ARE SEVERAL FACTORS THAT MAY IMPACT CORING TENDENCY. CORING FROM THE MEMBRANE MAY OCCUR DUE TO FRAGMENTATION CAUSED BY MULTIPLE INJECTIONS OR EXCESSIVE WELDING OF THE MEMBRANE. CORING OF THE RUBBER STOPPER MAY RESULT DEPENDING ON THE STOPPER QUALITY, THE DESIGN AND DIMENSIONS OF THE NEEDLES USED, OR IF A POOR CONNECTION OF THE PROTECTOR OCCURS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK N35C HAD FOREIGN MATTER IN THE DRUG VIAL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUBBER PARTICLE IN DRUG VIAL ¿ CANNOT BE IDENTIFIED IF P50 OR N35C.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PHASEAL¿ INJECTOR LUER LOCK N35C HAD FOREIGN MATTER IN THE DRUG VIAL. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RUBBER PARTICLE IN DRUG VIAL, CANNOT BE IDENTIFIED IF P50 OR N35C.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674232 BD PHASEAL INJECTOR LUER LOCK N35C INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515004 2003101 30382905150044

    Patients

    Seq Age Sex Outcome Treatment
    1 Other