BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE

    MDR report key: 13060509 · Received December 22, 2021

    Report

    Report Number
    1911916-2021-01284
    Event Type
    Malfunction
    Date Received
    December 22, 2021
    Date of Event
    November 18, 2021
    Report Date
    January 5, 2022
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    NGT
    UDI-DI
    30382903065463
    PMA / PMN Number
    K003553
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 12/17/2021. H.6. INVESTIGATION: IT WAS REPORTED THE WHITE TIP CAP WAS FOUND DEFORMED. TO AID IN THE INVESTIGATION, ONE SAMPLE IN A SEALED PACKAGING FLOW WRAP AND TWO PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED AND THE TIP CAP IS DAMAGED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF WHEN LOADING THE SYRINGE IN THE STERILIZATION TRAY IT WAS MISPLACED AND DAMAGED WHEN THE NEXT STERILIZATION TRAY WAS PUT ON TOP. THE PHOTOS PROVIDED SHOW THE SAMPLE 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. VERIFICATION OF THE STERILIZATION LOADING PROCESS WAS PERFORMED. THE SETTINGS WERE CORRECT AND PRODUCTS WERE BEING PLACED CORRECTLY. BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE HAD A DEFORMED TIP CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT THE WHITE TIP CAP WAS FOUND DEFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE HAD A DEFORMED TIP CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER COMPLAINED THAT THE WHITE TIP CAP WAS FOUND DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1963392 BD POSIFLUSH¿ IV FLUSH SOLUTION SODIUM CHLORIDE SALINE, VASCULAR ACCESS FLUSH NGT BD MEDICAL (BD WEST) MEDICAL SURGICAL 306546 1082924 30382903065463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown