BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD¿ CONTAINMENT TUBE

    MDR report key: 8827934 · Received July 25, 2019

    Report

    Report Number
    2243072-2019-01496
    Event Type
    Malfunction
    Date Received
    July 25, 2019
    Date of Event
    June 17, 2019
    Report Date
    July 25, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: BD HAD MADE MULTIPLE ATTEMPTS TO REACH THE CUSTOMER IN ORDER TO GATHER MORE INFORMATION ON THE CATALOG AND LOT NUMBER; HOWEVER, THE CUSTOMER INDICATED THAT THIS INFORMATION WAS NOT AVAILABLE. A GOOD FAITH EFFORT HAS BEEN MADE AND THIS COMPLAINT WILL BE CLOSED WITHOUT FURTHER INVESTIGATION AT THIS TIME. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS THERE WAS NO SAMPLE OR PHOTO AVAILABLE FOR EVALUATION, A ROOT CAUSE COULD NOT BE DETERMINED. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT THE UNSPECIFIED BD¿ CONTAINMENT TUBE HAS BEEN FOUND EXPERIENCING URINE SPLATTER DURING USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: UNKNOWN. BATCH NO: UNKNOWN. IT WAS REPORTED THE URINE TUBES WERE NOT DRAWING UP URINE. URINE TUBES NOT DRAWING UP URINE AND DRAW STRAW BROKE. DURING USE 2 RNS WERE UNABLE TO DRAW UP THE URINE INTO THE UC TUBE AND UA TUBE. ALSO NOTED THAT THE DRAW STRAW BROKE DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622501 UNSPECIFIED BD¿ CONTAINMENT TUBE CONTAINMENT TUBE FMH BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other