BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD LUER-LOK LUER-LOK TIP

    MDR report key: 8662779 · Received June 3, 2019

    Report

    Report Number
    2243072-2019-01069
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 20, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. PMA / 510(K)#: K980987 (IF (B)(6)) K151766 (IF (B)(6)). DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN. 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: NO CAPA IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPER IS DEFECTIVE WITH A 3 ML BD LUER-LOK¿ LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657, BATCH NO. UNKNOWN. IT WAS REPORTED THE STOPPER IS DEFECTIVE. CUSTOMER REPORTED THAT THE STOPPER ON THE SYRINGE SEEMS TO MOVE ON ITS OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    454978 3 ML BD LUER-LOK LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other