BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9%

    MDR report key: 12102786 · Received July 1, 2021

    Report

    Report Number
    1911916-2021-00622
    Event Type
    Injury
    Date Received
    July 1, 2021
    Date of Event
    March 7, 2021
    Report Date
    June 8, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IT WAS REPORTED BY THE DISTRIBUTOR THAT THE PLUNGERS ONLY MOVE HALFWAY UP THE BARREL OF THE SYRINGE AND NO FURTHER. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT COULD BE POSSIBLE THAT THE CUSTOMER IS GETTING SOME PRODUCTS THAT ARE TOWARDS THE HIGH SPECIFICATION LIMIT FOR PLUNGER MOVEMENT AND 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 306575, LOT NUMBER 1082945. 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 NO 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 2 BD POSIFLUSH¿ SP PRE-FILLED FLUSH SYRINGE NACL 0.9% PLUNGERS HAD DIFFICULT MOVEMENT DURING USE. AS A RESULT, THE NURSE BELIEVED THE CATHETER WAS PLUGGED AND ADMINISTERED CATHFLO MEDICATION TO THE PATIENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PLUNGERS ONLY MOVES HALFWAY UP THE BARREL OF THE SYRINGE AND THEN STOPS AND WON'T MOVE FURTHER. WE HAD A COUPLE OF PATIENTS RECEIVE CATHFLO (CLOT BUSTER) MEDICATION BECAUSE THE NURSE THOUGHT IT WAS THE VENOUS CATHETER THAT WAS PLUGGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996742 BD POSIFLUSH SP PRE-FILLED FLUSH SYRINGE NACL 0.9% SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 1082945

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention