BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 12971844 · Received December 9, 2021

    Report

    Report Number
    1911916-2021-01246
    Event Type
    Malfunction
    Date Received
    December 9, 2021
    Date of Event
    November 3, 2021
    Report Date
    January 5, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K161552
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION?: YES. D9: RETURNED TO MANUFACTURER ON: 12/16/2021. H6: INVESTIGATION: IT WAS REPORTED THAT IT FELT HARD TO PUSH DOWN THE PLUNGERS THOROUGHLY. TO AID IN THE INVESTIGATION, SIX EMPTY SAMPLES WITH NO PACKAGING FLOW WRAP AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE SAMPLES WERE THEN TESTED FOR SUSTAINING FORCE AND ALL RESULTS WERE WITHIN SPECIFICATION. IT COULD BE POSSIBLE THAT THE CUSTOMER IS GETTING SOME PRODUCTS THAT ARE TOWARDS THE HIGH SPECIFICATION LIMIT AND ARE RELATED TO THE SYMPTOM REPORTED BY THE CUSTOMER SINCE THEY REQUIRE EXTRA FORCE THAN NORMAL TO EXPEL THE SOLUTION. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT NUMBER 1082924. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER WAS DIFFICULT TO PUSH DOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER COMPLAINED THAT MANY NURSES FROM DIFFERENT DEPARTMENTS REPORTED THAT IT FELT HARD TO PUSH DOWN THE PLUNGERS THOROUGHLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE PLUNGER WAS DIFFICULT TO PUSH DOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CUSTOMER COMPLAINED THAT MANY NURSES FROM DIFFERENT DEPARTMENTS REPORTED THAT THEY FELT HARD TO PUSH DOWN THE PLUNGERS THOROUGHLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870745 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 1082924 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown