BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGE

    MDR report key: 17901547 · Received October 9, 2023

    Report

    Report Number
    1911916-2023-00752
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 18, 2023
    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
    CA
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES D.9. RETURNED TO MANUFACTURER ON: 13-OCT-2023 H.6. INVESTIGATION SUMMARY: IT WAS REPORTED, UPON ASPIRATING, THE PLUNGER SEPARATED FROM THE STOPPER IN THE SYRINGE. TO AID IN THE INVESTIGATION, TWO SAMPLES AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE IS AN EMPTY SYRINGE, AND THE OTHER SAMPLE HAS SOLUTION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE TWO PHOTOS PROVIDED SHOW SYRINGES IN A PLASTIC BAG. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THE FLUSH SYRINGES ARE DESIGNED TO PRESS THE PLUNGER ROD DOWN TO EXPEL THE SOLUTION. AFTER THE SOLUTION IS EXPELLED, THE UNIT NEEDS TO BE DISCARDED. THE UNIT IS NOT DESIGNED FOR ASPIRATION. IF THE PRODUCT IS NOT MEETING THE CUSTOMER¿S NEEDS, IT MAY BE BENEFICIAL TO CONTACT THE LOCAL BD SALES, OR MARKETING REPRESENTATIVE, FOR ADDITIONAL PRODUCT OPTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 3142754. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. 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. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE, STOPPER SEPARATED FROM THE PLUNGER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER. 10ML POSI -FLUSH WAS ATTACHED TO THE PATIENT POST DIALYSIS. PATIENT LINE WAS FLUSHED EASILY. UPON ASPIRATING, THE 10ML POSI-FLUSH PLUNGER SEPARATED FROM THE STOPPER IN THE SYRINGE. NO HARM TO PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHIKLE USING THE BD POSIFLUSH¿ NORMAL SALINE SYRINGE, STOPPER SEPARATED FROM THE PLUNGER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER. 10ML POSI -FLUSH WAS ATTACHED TO THE PATIENT POST DIALYSIS. PATIENT LINE WAS FLUSHED EASILY. UPON ASPIRATING, THE 10ML POSI-FLUSH PLUNGER SEPARATED FROM THE STOPPER IN THE SYRINGE. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923714 BD POSIFLUSH¿ NORMAL SALINE SYRINGE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 3142754 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown