BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ NORMAL SALINE SYRINGES,

    MDR report key: 16892666 · Received May 8, 2023

    Report

    Report Number
    1911916-2023-00283
    Event Type
    Malfunction
    Date Received
    May 8, 2023
    Date of Event
    April 13, 2023
    Report Date
    April 20, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    00382903065462
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE SYRINGE IS STUCK. TO AID IN THE INVESTIGATION, TWO EMPTY SAMPLES WITH NO PACKAGING FLOW WRAP AND ONE PHOTO WAS PROVIDED 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, WHICH IS THE FORCE APPLIED TO THE PLUNGER ROD WHILE MOVING DOWNWARDS WHEN EXPELLING THE SALINE SOLUTION AND THE RESULTS WERE WITHIN SPECIFICATION. THE PHOTO PROVIDED SHOWS THE SAMPLES RECEIVED. IT COULD BE POSSIBLE THE CUSTOMER IS NOT USING THE PRODUCT AS INTENDED. THE PRODUCT IS DESIGNED TO PUSH THE PLUNGER ROD DOWN WHILE FLUSHING THE IV LINE, NOT TO PULL BACK. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306546, LOT 3010578. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD POSIFLUSH¿ NORMAL SALINE SYRINGES, THE STOPPER WAS MISALIGNED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE HAVE BEEN MULTIPLE INCIDENCES. THERE WERE TWO STILL IN MY DOCUMENTATION FOR (B)(6) 2023 AND (B)(6) 2023. THESE ARE HAPPENING REGULARLY WITH DIFFERENT STAFF, DIFFERENT TYPES OF LINES AND DIFFERENT PATIENTS. IT IS NOT AN ISOLATED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639108 BD POSIFLUSH¿ NORMAL SALINE SYRINGES, SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 3010578 00382903065462

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown