BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP

    MDR report key: 7330824 · Received March 12, 2018

    Report

    Report Number
    1213809-2018-00144
    Event Type
    Malfunction
    Date Received
    March 12, 2018
    Date of Event
    February 22, 2018
    Report Date
    April 10, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: ONE OPEN 3ML PACKAGED SYRINGE WAS RECEIVED BY BD (B)(6) AND CONFIRMED TO BE FROM BATCH #6081881 (P/N 309657). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE NO VISUAL DEFECTS. THE SYRINGE WAS FILLED WITH WATER TO EVALUATE FOR LEAKAGE. A NEEDLE WAS ATTACHED TO THE SYRINGE AND THE WATER WAS DISPENSED THROUGH THE NEEDLE. NO LEAKAGE WAS OBSERVED. THE SYRINGE FUNCTIONED AS EXPECTED. THIS IS A SYRINGE ONLY PRODUCT. THE SAMPLE WAS RETURNED WITHOUT A NEEDLE ATTACHED. DHR REVIEW FOR BATCH 6081881 (P/N 309657): MANUFACTURING DATES: 04/14/2016 TO 04/15/2016. BATCH QUANTITY WAS (B)(6). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6081881 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: BASED ON THE EVALUATION PERFORMED THE DEFECT, AS NOTED BY THE END USER, CANNOT BE VERIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE A BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WAS FOUND LEAKING AS ¿UPON PUSHING THE PLUNGER, THE VACCINE CAME OUT NEAR THE ATTACHMENT OF THE NEEDLE TO THE SYRINGE AT THE LUER-LOK AND AT THE END OF THE NEEDLE. IN ADDITION, ANOTHER NEEDLE, WAS ATTACHED FIRMLY TO THE SYRINGE BUT THE VACCINE AGAIN CAME OUT AT THE ATTACHMENT OF THE NEEDLE TO THE SYRINGE AT THE LUER-LOK TIP. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175931 BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP CONVENTIONAL SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 6081881 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other