BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8584429 · Received May 6, 2019

    Report

    Report Number
    3003152976-2019-00310
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 10, 2019
    Report Date
    May 17, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTGATION: TWO SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT ALL SAMPLES DO NOT HAVE A TIP. USING MAGNIFICATION TO FURTHER EVALUATE, THE THREAD OF THE BARREL IS NOTED TO BE COMPLETE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1901240 FINDING ONE ANNOTATION RELATED TO THIS MALFUNCTION. DURING THE MOLDING PROCESS, AN INCIDENT WAS DETECTED IN ONE OF THE MOLDING CAVITIES WHICH CAUSED THE BARRELS TO BE EXPULSED FROM THE MOLD AND RESULTED IN THE TIP DETACHING, SUCH AS SEEN IN THE PRODUCT REPORTED. ONCE THE ISSUE WAS DETECTED, THE CAVITY WAS REPAIRED AND DEFECTIVE PRODUCT WAS SCRAPPED. IT HAS BEEN DETERMINED THIS INSTANCE OCCURRED AS A RESULT OF BOTH THE MALFUNCTION NOTED AND PRODUCT NOT BEING PROPERLY REJECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE (DROP BY DROP) AT THE SCREW THREAD OF THE SYRINGE. WHEN I LOOK CLOSER, I THINK THAT I DID NOT SCREW THE EXTENSION ON THE SYRINGE, WHICH I TRY TO DO, BUT THE DRIP CONTINUES ANYWAY. THE SCREW THREAD OF THE SYRINGE WAS ACTUALLY COMPLETELY BROKEN. IN ADDITION, THE TENSION OF MY PATIENT BEGAN TO DECREASE BECAUSE THIS SYRINGE INFUSED THE PATIENT'S KTC PATHWAY ASSOCIATED WITH NORADRENALINE."

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LEAKAGE (DROP BY DROP) AT THE SCREW THREAD OF THE SYRINGE. WHEN I LOOK CLOSER, I THINK THAT I DID NOT SCREW THE EXTENSION ON THE SYRINGE, WHICH I TRY TO DO, BUT THE DRIP CONTINUES ANYWAY. THE SCREW THREAD OF THE SYRINGE WAS ACTUALLY COMPLETELY BROKEN. IN ADDITION, THE TENSION OF MY PATIENT BEGAN TO DECREASE BECAUSE THIS SYRINGE INFUSED THE PATIENT'S KTC PATHWAY ASSOCIATED WITH NORADRENALINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374316 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1901240 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other