BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 5/8 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6358159 · Received February 24, 2017

    Report

    Report Number
    8041187-2017-00016
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    February 4, 2017
    Report Date
    March 22, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: FMI AND FMF. PMA/510(K)#: K941562 (SYRINGE) AND K010188 (NEEDLE). RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD AND QUALITY NOTIFICATIONS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6049433. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. 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. REMEDIAL ACTION REQUIRED: CAPAS (B)(4) HAVE BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: THREE SAMPLES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT TWO OF THE UNITS WERE USED AND THEIR SAFETY MECHANISMS WERE APPROPRIATELY ACTIVATED. ONE SAMPLE WAS UNUSED AND IN A SEALED PACKAGE. THE UNUSED UNIT WAS EXAMINED AND THE SAFETY COVER ACTIVATED PROPERLY WITH NO ISSUES OBSERVED. THE DHR AND MANUFACTURING REVIEW WAS PREVIOUSLY REPORTED AND NO ISSUES WERE IDENTIFIED. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NURSE USED A 25 G X 5/8 IN. BD ECLIPSE 1 ML BD LUER-LOK SYRINGE WITH DETACHABLE NEEDLE TO INJECT INTO EXTENSION TUBING. SHE ACTIVATED THE SAFETY SHIELD AND HEARD A CLICK, BUT AS SHE UNSCREWED THE NEEDLE FROM THE SYRINGE, SHE WAS STUCK WITH THE NEEDLE. THE NEEDLE DID NOT COME INTO CONTACT WITH THE PATIENT AND THEREFORE NO MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141674 25 G X 5/8 IN. BD ECLIPSE¿ 1 ML BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SAFETY ENGINEERED SYRINGE AND NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6049433

    Patients

    Seq Age Sex Outcome Treatment
    1 Other