BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER -LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7890426 · Received September 19, 2018

    Report

    Report Number
    8041187-2018-00361
    Event Type
    Malfunction
    Date Received
    September 19, 2018
    Date of Event
    August 9, 2018
    Report Date
    September 24, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057795
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE RETURNED SAMPLE RECEIVED FOR INVESTIGATION. THE RETURNED SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND HUB LEAK TEST. BASED ON THE VISUAL INSPECTION AND HUB LEAK TEST, THE SAMPLE PASSED BOTH ACCEPTANCE CRITERIA. DURING THE VISUAL INSPECTION AND HUB LEAK TEST, THERE WAS NO CLOGGED NEEDLE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: BASED ON THE INVESTIGATION FINDING, WE ARE NOT ABLE TO CONFIRM THE DEFECT. AS SUCH, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER -LOK¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. PMA/510(K)#: K980987(SYRINGE); K161170 (NEEDLE). 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 BD LUER -LOK¿ SYRINGE WITH DETACHABLE NEEDLE LEAKED. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    731426 BD LUER -LOK¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7176198 00382903057795

    Patients

    Seq Age Sex Outcome Treatment
    1 Other