BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP, 23 G X 1 IN BD ECLIPSE¿ NEEDLE

    MDR report key: 6271374 · Received January 23, 2017

    Report

    Report Number
    9617032-2017-00001
    Event Type
    Malfunction
    Date Received
    January 23, 2017
    Date of Event
    December 16, 2016
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. TEN RETAINED SAMPLES FROM THE SAME LOT NUMBER WERE TESTED FOR SAFETY SHIELD DEFECTS. ALL ACTIVATED CORRECTLY, WITH NONE DETACHING. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO QUALITY NOTIFICATIONS OR IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6141897. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE AND THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETAINED SAMPLES. ADDITIONALLY, OUR QUALITY ENGINEER NOTES THAT A POTENTIAL ROOT CAUSE FOR THIS TYPE OF DEFECT IS THAT LATERAL PRESSURE WAS PLACED ON THE SHIELD WHILE IT WAS BEING PUSHED INTO PLACE. THIS CAN HAVE THE EFFECT OF PUSHING THE SHIELD OUT OF THE PIVOT.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: TWO SAMPLES WERE RETURNED BY THE CUSTOMER IN SUPPORT OF THIS COMPLAINT, AND NO PHOTOS WERE ATTACHED. THE TWO RETURNED, TOGETHER WITH 10 RETAINED SAMPLES FROM THE SAME LOT NUMBER WERE THEREFORE, TESTED FOR SAFETY SHIELD DEFECTS. ALL ACTIVATED CORRECTLY, WITH NONE DETACHING. DHR/BHR REVIEW: NO QNS OR OTHER ISSUES RELATING TO THE REPORTED DEFECT WERE IDENTIFIED IN THE DHR. INVESTIGATION CONCLUSION: THE COMPLAINT WAS NOT CONFIRMED DUE TO THE INABILITY TO REPLICATE THE CUSTOMER¿S FAILURE MODE. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE RETURNED AND RETAINED SAMPLES. ROOT CAUSE DESCRIPTION: THE MOST LIKELY ROOT CAUSE FOR THIS TYPE OF DEFECT IS THAT LATERAL PRESSURE WAS PLACED ON THE SHIELD WHILST IT WAS BEING PUSHED INTO PLACE. THIS CAN HAVE THE EFFECT OF PUSHING THE SHIELD OUT OF THE PIVOT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER AN ARTERIAL BLOOD GAS COLLECTION, THE NEEDLE PROTECTION OF A 3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP, 23 G X 1 IN BD ECLIPSE¿ NEEDLE CAME OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52275 3 ML BD PRESET¿ SYRINGE WITH BD LUER-LOK¿ TIP, 23 G X 1 IN BD ECLIPSE¿ NEEDLE BLOOD GAS ANALYSIS SYRINGE JKA BECTON, DICKINSON AND COMPANY (BD) 6141897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other