BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 7190825 · Received January 15, 2018

    Report

    Report Number
    8041187-2017-00292
    Event Type
    Malfunction
    Date Received
    January 15, 2018
    Date of Event
    December 22, 2017
    Report Date
    March 23, 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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    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 12/29/2016. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED NO SAMPLES FROM THE CUSTOMER FOR EXAMINATION IN SUPPORT OF THIS COMPLAINT. QUALITY HAS PREVIOUSLY REVIEWED, EVALUATED AND INVESTIGATED THIS REPORTED FAILURE MODE. A CAPA EXISTS TO FURTHER INVESTIGATE. NO FURTHER 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 MONTHLY. CONCLUSION: UNABLE TO DETERMINE A ROOT CAUSE SINCE NO SAMPLES WERE RECEIVED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: SEVEN REPRESENTATIVE SAMPLES OF BATCH 6106446 WERE RETURNED IN SEALED PACKAGE FOR INVESTIGATION, NO DAMAGE WAS OBSERVED ON THE SAFETY SHIELD. THE SAMPLES WERE SUBJECTED TO SAFETY SHIELD FALL OFF/BREAK OFF TEST, NONE OF THE SAFETY SHIELD WAS DISENGAGED. NO ABNORMALITY OR QN WERE REPORTED ON THE AFFECTED BATCH 6106446 DURING PRODUCTION. INVESTIGATION CONCLUSION: THE SAFETY SHIELDS WERE FOUND TO BE INTACT AND PASSED SAFETY SHIELD TEST. HENCE, ROOT CAUSE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED AFTER USE OF THE BD ECLIPSE¿ NEEDLE THE PINK SAFETY SHIELD FALLS OFF. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36085 BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6106446 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other