BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PHASEAL PROTECTOR P50

    MDR report key: 10210437 · Received June 29, 2020

    Report

    Report Number
    3003152976-2020-00279
    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
    30382905151058
    PMA / PMN Number
    K123213
    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 EVAL: YES. D.10 RETURNED TO MANUFACTURER ON: 2020-09-03. H.6. INVESTIGATION SUMMARY: NO PROTECTOR SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. PHOTOS AND TWO SAMPLE INJECTORS THAT WERE USED WITH THE PROTECTOR WERE PROVIDED. THE PHOTOS WERE VISUALLY INSPECTED AND SMALL WHITE PARTICLES CAN BE SEEN ON THE CANNULA OF THE INJECTOR. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2001121 AND 2002156, 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 THE REPORTED LOTS AND RESULTS WERE FOUND TO BE ACCEPTABLE. FOUR RETAINED SAMPLES OF BOTH LOT 2001121 AND 2002156 WERE USED FOR ADDITIONAL EVALUATION. FUNCTIONAL TESTING WAS ALSO PERFORMED, PENETRATING THE PROTECTOR WITH A SAMPLE INJECTOR FROM LOT 2003101. 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. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A RUBBER PARTICLE, POTENTIALLY FROM THE BD PHASEAL¿ PROTECTOR P50, WAS FOUND IN THE DRUG VIAL BEFORE USE. LOTS 2001121 AND 2002156 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. 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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2001121. DEVICE MANUFACTURE DATE: 2020-01-16. MEDICAL DEVICE LOT #: 2002156. DEVICE MANUFACTURE DATE: 2020-03-02. 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 A RUBBER PARTICLE, POTENTIALLY FROM THE BD PHASEAL¿ PROTECTOR P50, WAS FOUND IN THE DRUG VIAL BEFORE USE. LOTS 2001121 AND 2002156 WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 2 RELATED INCIDENTS. 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
    674271 BD PHASEAL PROTECTOR P50 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515105 SEE SECTION H.10. 30382905151058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other