BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLASTIC URINE COLLECTION CUP

    MDR report key: 6127045 · Received November 24, 2016

    Report

    Report Number
    9617032-2016-00005
    Event Type
    Malfunction
    Date Received
    November 24, 2016
    Date of Event
    November 3, 2016
    Report Date
    January 6, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    NZU
    PMA / PMN Number
    K790366
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: ONE USED SAMPLE AND THREE PHOTOS WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE AND PHOTOS REVEALED A URINE CUP WITH THE EXTRA BENT AND DAMAGED NEEDLE INSIDE THE CUP. THE PHOTOS SHOWED THE POSITION OF THE EXTRA NEEDLE WHEN THE SECRETARY PRICKED HER FINGER ON IT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6190792. CONCLUSION: ALTHOUGH THE VISUAL INSPECTION CONFIRMED THE CUSTOMER'S INDICATED FAILURE MODE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. OUR QUALITY ENGINEER NOTES THAT THE MOST LIKELY ROOT CAUSE WAS THAT THE EXTRA NEEDLE BECAME CAUGHT AND DAMAGED IN THE ASSEMBLY MACHINERY DUE TO TIMING ERROR ISSUES. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR MONITORING OF CURRENT TRENDS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SECRETARY OBTAINED A CLEAN NEEDLE STICK INJURY FROM AN UNUSED BD VACUTAINER® PLASTIC URINE COLLECTION CUP. THE NEEDLE WAS BENT AND STICKING OUT FROM UNDER THE LABEL. THERE WAS NO REPORT OF MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777480 BD VACUTAINER® PLASTIC URINE COLLECTION CUP COLLECTION CUP NZU BECTON, DICKINSON AND COMPANY (BD) 6190792

    Patients

    Seq Age Sex Outcome Treatment
    1 Other