BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD POSIFLUSH

    MDR report key: 18434781 · Received January 3, 2024

    Report

    Report Number
    3002682307-2023-00366
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 8, 2023
    Report Date
    April 29, 2024
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    NGT
    PMA / PMN Number
    UKN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. NUMEROUS LOT NUMBERS PROVIDED, BUT THE CUSTOMER WAS NOT ABLE TO VERIFY WHICH IF ANY WERE AFFECTED: "THEREFORE, THE LOT IS NOT KNOWN AND CANNOT BE EVALUATED. THE FOLLOWING LOTS WERE DELIVERED TO THE HEALTHCARE FACILITY IN THE PERIOD FROM THE END OF AUGUST TO THE END OF NOVEMBER 2023". DELIVERY / LOT: 22.11.23: 32702 02.11.23: 3241284 16.10.23: 3249900 02.10.23: 3228924 14.09.23: 3199120 25.08.23: 3193790.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 306575 AND POTENTIAL LOT NUMBERS 3193790, 3199120, 3228924, 3249900, 3241284, 3270281. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE AND THE AFFECTED PHYSICAL SAMPLE WERE RETURNED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE SAMPLES, THE SYRINGE WAS OBSERVED IN A SEALED UNIT PACKAGE WITH THE BARREL LABEL MISSING. AN ADDITIONAL TWO (2) SHELF CARTONS OF RETAINED SAMPLES FOR EACH OF THE POTENTIAL LOT NUMBERS WERE OBTAINED FROM THE MANUFACTURING FACILITY. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS WERE IDENTIFIED. ALTHOUGH AN EXACT CAUSE WAS NOT IDENTIFIED DURING THE PRODUCTION PROCESS, IT IS MOST LIKELY THAT THE MISSING BARREL LABEL RESULTED FROM AN ERROR IN THE DOUBLE REJECTION STATION. THERE IS A VISION SYSTEM IN PLACE TO DETECT MISSING LABELS. IF THERE IS NO LABEL, THE REJECTION STATION MUST REJECT THE SYRINGE; HOWEVER, IF THERE IS A FAILURE IN THE REJECTION, THE MACHINE STOPS AND THE OPERATOR MUST RESOLVE THE ISSUE. IT IS POSSIBLE THAT AN ERROR OCCURRED WITH THIS PROCESS OR THAT THE DETECTION SENSOR WAS NOT DETECTING PROPERLY. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD POSIFLUSH IS MISSING LABELING IN ITS BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: UNLABELED PREFILLED SYRINGE. NO LABEL. PREFILLED SYRINGE IS NOT LABELED (NO LABEL). CONTENTS NOT KNOWN. THE SYRINGE WAS NOT REMOVED FROM THE ORIGINAL PACKAGING (CARTON). WHEN DID THE INCIDENT OCCUR? BEFORE USE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1507584 BD POSIFLUSH SALINE VASCULAR ACCESS FLUSH NGT BECTON DICKINSON, S.A. INCORRECT ENTRY

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown