BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INJECTOR LUER LOCK N35

    MDR report key: 9193511 · Received October 15, 2019

    Report

    Report Number
    3003152976-2019-00727
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    October 1, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    30382905150037
    PMA / PMN Number
    K140591
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND A ROOT CAUSE COULD BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF INJECTOR LUER LOCK N35 EXPERIENCED CONNECTOR LOOSE OR SEPARATION OF CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 5251003; BATCH NO.: UNKNOWN. PER COMPLAINT FORM: WE ARE HAVING SOME PROBLEMS WITH PATIENTS ON CONTINUOUS INFUSIONS WITH PHASEAL COMING DISCONNECTED.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF INJECTOR LUER LOCK N35 EXPERIENCED CONNECTOR LOOSE OR SEPARATION OF CONNECTOR AND INJECTOR DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 5251003 BATCH NO.: UNKNOWN. PER COMPLAINT FORM: WE ARE HAVING SOME PROBLEMS WITH PATIENTS ON CONTINUOUS INFUSIONS WITH PHASEAL COMING DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983893 INJECTOR LUER LOCK N35 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. UNKNOWN 30382905150037

    Patients

    Seq Age Sex Outcome Treatment
    1 Other