BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 9279759 · Received November 5, 2019

    Report

    Report Number
    1213809-2019-01104
    Event Type
    Malfunction
    Date Received
    November 5, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 19, 2019
    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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD LUBRICANT ON THE PLUNGER WHEN IT OPENED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657, BATCH NO.: 9130796. IT WAS REPORTED THERE WAS A LUBRICANT ON THE PLUNGER WHEN OPENED. PER EMAIL: REPORTING A QUALITY ISSUE. A 3ML SYRINGE FROM BD WAS OPENED, AND IT LOOKS LIKE THERE IS SOME KIND OF LUBRICANT ON THE PLUNGER.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THE CUSTOMER'S ADDRESS IS UNKNOWN. (B)(6) USA HAS BEEN USED AS A DEFAULT. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP HAD LUBRICANT ON THE PLUNGER WHEN IT OPENED. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309657 BATCH NO.: 9130796. IT WAS REPORTED THERE WAS A LUBRICANT ON THE PLUNGER WHEN OPENED. PER EMAIL: REPORTING A QUALITY ISSUE. A 3ML SYRINGE FROM BD WAS OPENED, AND IT LOOKS LIKE THERE IS SOME KIND OF LUBRICANT ON THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1070949 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9130796 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Other