BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6136117 · Received November 30, 2016

    Report

    Report Number
    8041187-2016-00087
    Event Type
    Malfunction
    Date Received
    November 30, 2016
    Date of Event
    November 13, 2016
    Report Date
    January 23, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    SECTION H.10
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: 132 SEALED SAMPLES WERE RETURNED FOR EVALUATION. THIRTY SEALED SAMPLES WERE SELECTED AT RANDOM FOR INSPECTION. THE SAMPLES WERE VISUALLY INSPECTED. NO DEFECTS OR ABNORMALITIES WERE NOTED. THE SAMPLES WERE THEN ACTIVATED PER THE IFU. ELEVEN OF THE SAMPLES HAD CLICKING DURING ACTIVATION. THIS IS WHERE THE SAFETY MECHANISM IS BROUGHT UP TO COVER THE NEEDLE HOWEVER BEFORE THE SAFETY CAN COVER THE NEEDLE A CLICK CAN BE HEARD. NORMALLY DURING ACTIVATION A CLICK CAN BE HEARD WHEN THE NEEDLE HAS COMPLETELY COVERED THE NEEDLE. IN THIS CASE THIS ¿FALSE CLICK¿ CAN CAUSE THE USER TO BELIEVE THE SAFETY HAS COVERED THE NEEDLE EVEN THOUGH IT IS STILL EXPOSED. THE OTHER 19 SEALED SAMPLES HAD NO ISSUES OR ABNORMALITIES DURING/AFTER ACTIVATION. AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY AND MANUFACTURING RECORDS AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5141153. CONCLUSION: ALTHOUGH BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. THE SAMPLES HAVE BEEN FORWARDED TO THE MANUFACTURING SITE IN (B)(4) FOR A SECONDARY INVESTIGATION. UPON COMPLETION OF THE ADDITIONAL INVESTIGATION, A SECOND SUPPLEMENTAL MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    MEDICAL DECIVE TYPE: FMI AND FMF. PMA / 510(K) #: K941562 (SYRINGE) AND K010188 (NEEDLE). RESULTS: A SAMPLE HAS BEEN RETURNED BUT HAS NOT YET BEEN EVALUATED. HOWEVER, THE MANUFACTURING SITE CONDUCTED A NO SAMPLE INVESTIGATION ON 11/23/2016. A REVIEW OF THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5141153. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THIS ISSUE. CONCLUSION: A CONCLUSION IS NOT YET AVAILABLE AS THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. OF NOTE, CAPA (B)(4) HAS BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: ONE HUNDRED AND ONE REPRESENTATIVE SAMPLES (NINETY-ONE IN PACKAGING AND TEN WITHOUT PACKAGING) WERE RETURNED TO THE MANUFACTURING FACILITY IN (B)(4) FOR A SECONDARY INVESTIGATION. A SIMULATED USE TEST DID NOT OBSERVE SAFETY SHIELD DISENGAGEMENT ON THE RETURNED SAMPLES. TWENTY-SIX OF THE ONE HUNDRED AND ONE SAMPLES OBSERVED A "CLICK" SOUNDS UPON ACTIVATION. CONCLUSION: ALTHOUGH BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. CAPAS (B)(4) HAVE BEEN INITIATED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A 27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE, A CLINICIAN HEARD TWO CLICKS AFTER ENGAGING THE SAFETY MECHANISM BUT THE SAFETY DID NOT ENGAGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787977 27 G X 1/2 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 5141153

    Patients

    Seq Age Sex Outcome Treatment
    1 Other