BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 7060559 · Received November 27, 2017

    Report

    Report Number
    1213809-2017-00272
    Event Type
    Injury
    Date Received
    November 27, 2017
    Date of Event
    October 18, 2017
    Report Date
    January 26, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096047
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: TWO PHOTOS WERE RECEIVED BY BD CANAAN AND EVALUATED. ONE PHOTO DEPICTED PACKAGE FROM BATCH #7122961 (P/N (B)(4)). IN THE SECOND PHOTO ONLY A PART OF THE BARREL WAS VISIBLE WITH BD LOGO AND PARTIALLY VISIBLE SCALE MARKINGS. A PLUNGER ROD WAS NEXT TO THE BARREL COVERED WITH A POST-IT NOTE, SO ONLY PARTS OF IT WERE VISIBLE. THE RETAINING RING INSIDE THE BARREL WAS CLEARLY VISIBLE. NO VISIBLE DEFECTS WERE OBSERVED IN THE PHOTOS. DHR REVIEW FOR BATCH 7122961 (P/N (B)(4)): MANUFACTURING DATES: 05/18/2017 TO 05/20/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7122961 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. CONCLUSION: UNCONFIRMED: BD CANAAN WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. END-USER ERROR.

    Additional Manufacturer Narrative · 1

    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 A BD LUER-LOK¿ TIP SYRINGE MALFUNCTIONED AS THEY DREW THE PATIENT'S 0400 AMMONIA LAB OUT OF HIS BROVIAC USING THE STOPCOCK METHOD, THE PLUNGER OF THE SYRINGE POPPED OUT OF THE SYRINGE BARREL WITH THE SEAL COMING OFF AS WELL. THE LINE WAS CLAMPED AND THE STOPCOCK WAS REMOVED. A PERIPHERAL STICK WAS THEN USED TO OBTAIN THE BLOOD DRAW. THE DOCTORS WERE CALLED AND NOTIFIED OF WHAT HAPPENED AND LABS AND IMAGING WERE REQUESTED. IT WAS STATED THAT THERE WERE NO LABS OR IMAGING THAT COULD BE DONE AT THIS TIME. THE PATIENT WAS ASSESSED AND PLACED ON CARDIORESPIRATORY MONITORS AND MONITORED CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839424 BD LUER-LOK¿ TIP SYRINGE SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7122961 30382903096047

    Patients

    Seq Age Sex Outcome Treatment
    1 Other