BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE

    MDR report key: 12676604 · Received October 21, 2021

    Report

    Report Number
    1911916-2021-01102
    Event Type
    Malfunction
    Date Received
    October 21, 2021
    Date of Event
    September 21, 2021
    Report Date
    September 27, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065470
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S ADDRESS IS UNKNOWN. UNKNOWN, (B)(6) USA HAS BEEN USED AS A DEFAULT. INVESTIGATION SUMMARY: IT WAS REPORTED THAT THE SYRINGES WERE NOT FLUSHING. TO AID IN THE INVESTIGATION, FOUR SAMPLES, TWO IN SEALED PACKAGING FLOW WRAPS AND TWO IN NO PACKAGING FLOW WRAPS, WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH 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 ALL RESULTS WERE WITHIN SPECIFICATION. IT COULD BE POSSIBLE THAT UNITS RECEIVED 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 306547, LOT NUMBER 1160571. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE HAD DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A FEW REPORTS OF ISSUES WITH THE 10ML NS SYRINGES NOT FLUSHING SMOOTHLY. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1572326 BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306547 1160571 30382903065470

    Patients

    Seq Age Sex Outcome Treatment
    1