BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 7283895 · Received February 20, 2018

    Report

    Report Number
    8041187-2018-00037
    Event Type
    Malfunction
    Date Received
    February 20, 2018
    Date of Event
    February 1, 2018
    Report Date
    March 14, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE RETURNED PHOTO AND CONFIRMED THAT THE SAFETY SHIELD WAS DISENGAGED FROM THE HUB. SINCE NO SAMPLES ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. THE COMPLAINT HISTORY WAS REVIEWED AND NO SIMILAR COMPLAINTS WERE RECEIVED ON THE AFFECTED BATCH 7114176. DHR REVIEW SHOWED NO ABNORMALITY OR QN REPORTED ON THE AFFECTED BATCH 7114176 DURING PRODUCTION. THE MANUFACTURING RECORDS REVIEWED PREVENTIVE MAINTENANCE, CALIBRATION, AND EQUIPMENT, AND NO ABNORMALITY WAS OBSERVED THAT COULD HAVE INFLUENCED THIS ISSUE. WITHOUT SAMPLES, NO ROOT CAUSE CAN BE DETERMINED. HOWEVER, QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED, AND INVESTIGATED THIS REPORTED FAILURE MODE. CAPA (B)(4) EXISTS TO FURTHER INVESTIGATE THE ISSUE. THE COMPLAINT WILL BE RE-OPENED IF THE SAMPLE IS RETURNED FOR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    CAPAS (B)(4) WERE 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 (B)(6) 2016. (B)(6) A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED BEFORE USE OF THE BD ECLIPSE¿ NEEDLE THE SAFETY DEVICE BROKE OFF THE NEEDLE WHILE ATTACHING THE NEEDLE TO THE SYRINGE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125771 BD ECLIPSE¿ NEEDLE NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 7114176 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other