BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ PRE-FILLED SYRINGE

    MDR report key: 12715742 · Received October 28, 2021

    Report

    Report Number
    1911916-2021-01116
    Event Type
    Malfunction
    Date Received
    October 28, 2021
    Date of Event
    June 30, 2021
    Report Date
    October 9, 2021
    Product Code
    FOZ
    UDI-DI
    00382903065462
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE PLUNGER WOULD NO LONGER MOVE. TO AID IN THE INVESTIGATION, ONE SAMPLE WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THE RUBBER STOPPER IS AT THE 2.5ML MARK OF THE SCALE AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLE WAS THEN TESTED FOR SUSTAINING FORCE, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION, AND THE RESULT WAS WITHIN SPECIFICATION. IT COULD BE POSSIBLE THAT PARTS THAT ARE TOWARDS THE HIGH SPECIFICATION LIMIT ARE RELATED TO THE SYMPTOM REPORTED BY THE CUSTOMER SINCE THEY REQUIRE EXTRA FORCE THAN NORMAL TO EXPEL THE SOLUTION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT NUMBER 1203808. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. PREVIOUS INVESTIGATIONS HAVE REVEALED THAT IMPROPER SILICONE APPLICATION WITHIN THE SYRINGE BARREL CAN CREATE PLUNGER RESISTANCE. SEVERAL QUALITY INITIATIVES HAVE BEEN IMPLEMENTED ON OUR MANUFACTURING LINE TO ENSURE THAT THE SILICONE APPLICATION IS PROPERLY APPLIED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A MONITORING PROGRAM IS ALSO IN PLACE TO VERIFY THE SILICONE IS UNIFORMLY APPLIED TO THE SYRINGE BARREL. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH¿ PRE-FILLED SYRINGE PLUNGER WOULD NOT MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE RN REPORTED THAT THE PLUNGER WOULD NO LONGER MOVE. VERBATIM: PER REPORT - THE RN WAS PUSHING THE FLUID FROM THE FLUSH INTO THE LINE AFTER STARTING AN IV AND STOPPED PUSHING. THE PLUNGER WOULD NO LONGER MOVE. THIS MAKES IT SEEM AS IF THE IV IS BAD. THIS COULD ALSO BE AN ISSUE IF YOU ARE FLUSHING MEDICATIONS LIKE ADENOSINE WHICH HAS A VERY SHORT HALF LIFE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1609694 BD POSIFLUSH¿ PRE-FILLED SYRINGE SALINE, VASCULAR ACCESS FLUSH FOZ 1203808 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1