BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 5470426 · Received March 1, 2016

    Report

    Report Number
    3002682307-2016-00001
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 4, 2016
    Report Date
    March 17, 2016
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    SEE H.10.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THERE ARE TWO 510(K) NUMBERS LISTED FOR THIS DEVICE; K010188 AND K043397. DEVICE MANUFACTURE DATE: SEPTEMBER, 2015. RESULTS: IT IS UNKNOWN IF A SAMPLE WILL BE RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 1509011. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. IT IS UNKNOWN IF A SAMPLE IS AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. HOWEVER, RETENTION SAMPLES FROM THE SAME LOT # WERE EVALUATED. ENGAGEMENT TESTS WERE PERFORMED WITH 15 SAMPLES WITH ACCEPTABLE RESULTS: AVERAGE VALUE: 4,48LB (3,5 < X > 10LB). AS PREVIOUSLY REPORTED, A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 1509011. CONCLUSION: WITHOUT A SAMPLE AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 25 G X 5/8 IN. BD ECLIPSE NEEDLE TO ADMINISTER THE CHEMOTHERAPY MEDICATION AZACITIDINE SUBCUTANEOUSLY TO A PATIENT, THERE WAS A LEAKAGE OF THE MEDICATION FROM WHERE THE NEEDLE WAS ATTACHED TO A SYRINGE AND A SLIGHT SPILLAGE OF MEDICATION ONTO THE PATIENT'S SKIN. IT WAS ALSO REPORTED THAT THE NEEDLE WAS CORRECTLY SITED WITHIN THE SYRINGE. THE PATIENT WAS ASSESSED AND THE EXPOSED AREA THOROUGHLY CLEANSED WITH WIPES. THE PATIENT WAS ADVISED TO MONITOR THE AREA OVERNIGHT AND TO CONTACT TRIAGE/HAEM WARD WITH ANY WORRIES OR CONCERNS. NO MEDICAL INTERVENTIONS WERE PROVIDED AND THERE WAS NO REPORT OF INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127215 25 G X 5/8 IN. BD ECLIPSE¿ NEEDLE HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 1509011

    Patients

    Seq Age Sex Outcome Treatment
    1 Other