BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE

    MDR report key: 7329890 · Received March 11, 2018

    Report

    Report Number
    1213809-2018-00116
    Event Type
    Malfunction
    Date Received
    March 11, 2018
    Date of Event
    October 23, 2017
    Report Date
    April 4, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903095780
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. WE WOULD BE VERY INTERESTED IN EXAMINING PRODUCT THAT DOES NOT MEET YOUR EXPECTATIONS AND OUR QUALITY STANDARDS. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. DHR REVIEW FOR BATCH 7156968 (P/N 309578): MANUFACTURING DATES: 06/26/2017 TO 06/27/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7156968 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW FOR BATCH 7122642 (P/N 309578): MANUFACTURING DATES:05/16/2017 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 7122642 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED.

    Additional Manufacturer Narrative · 1

    "THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7122642. MEDICAL DEVICE EXPIRATION DATE: 04/30/2022. DEVICE MANUFACTURE DATE: 05/02/2017. MEDICAL DEVICE LOT #: 7156968. MEDICAL DEVICE EXPIRATION DATE: 05/31/2022. DEVICE MANUFACTURE DATE: 06/05/2017. 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 THE BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE LEAKED RADIOACTIVE FLUID DOWN THE SIDE OF THE BARREL THROUGH A CRACK. THERE WAS NO REPORTS OF EXPOSURE OR SERIOUS INJURY. NO MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172919 BD LUER-LOK¿ SYRINGE WITH PRECISIONGLIDE¿ DETACHABLE NEEDLE SYRINGE AND NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 00382903095780

    Patients

    Seq Age Sex Outcome Treatment
    1 Other