BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 G X 1 IN. BD ECLIPSE¿ NEEDLE

    MDR report key: 6294725 · Received February 1, 2017

    Report

    Report Number
    8041187-2017-00010
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 16, 2017
    Report Date
    March 10, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A LOT NUMBER FOR THIS INCIDENT WAS PROVIDED WITH RETURNED SAMPLES ON 2/22/2017. THE INFORMATION FOR THE LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6140350, MEDICAL DEVICE EXPIRATION DATE: 05/31/2021, DEVICE MANUFACTURE DATE: 05/19/2016. DEVICE EVALUATION: ONE HUNDRED UNUSED AND SEALED SAMPLES WERE RETURNED FOR EVALUATION. THIRTY OF THE UNITS WERE RANDOMLY SELECTED AND ACTIVATED ACCORDING TO THE STEPS IN THE IFU. THE SAFETY MECHANISMS DID NOT BREAK OFF DURING ACTIVATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6140350. A MANUFACTURING REVIEW REVEALED NO ABNORMALITIES WITH PREVENTATIVE MAINTENANCE, CALIBRATION, OR EQUIPMENT THAT COULD HAVE INFLUENCED THE CUSTOMER'S REPORTED ISSUE. 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. REMEDIAL ACTION REQUIRED: AS PREVIOUSLY REPORTED, CAPAS (B)(4) WERE OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT, FIELD ACTION NOTIFICATION MSS-16-837-FA WAS INITIATED, AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. THE CUSTOMER HAS INDICATED A SAMPLE IS AVAILABLE FOR EVALUATION, BUT SAMPLES HAVE NOT BEEN RETURNED. THE MANUFACTURING SITE IN (B)(4) HAS COMPLETED A NO SAMPLE INVESTIGATION FOR THE REPORTED CATALOG # 305761. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. 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 AND A SAMPLE HAS NOT YET BEEN RETURNED FOR EVALUATION. HOWEVER, (B)(4) HAVE BEEN OPENED TO IDENTIFY AND ADDRESS THE POTENTIAL CAUSES OF SAFETY SHIELD DISENGAGEMENT. ADDITIONALLY, FIELD ACTION NOTIFICATION MSS-16-837-SA WAS INITIATED AND A PRODUCT ADVISORY LETTER WAS SENT ON 12/29/2016. IN THE EVENT THAT SAMPLES ARE RETURNED FOR EVALUATION, A SUPPLEMENTAL REPORT WILL BE FILED FOR THE INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WHILE A CLINICIAN WAS GIVING A (B)(6) OLD MALE PATIENT A HIB VACCINATION WITH A 25 G X 1 IN. BD ECLIPSE¿ NEEDLE, THE PINK SAFETY SHIELD OF THE NEEDLE SLIPPED OFF, CAUSING THE NEEDLE TO PUNCTURE THE CLINICIAN'S FINGER WHILE SHE WAS INJECTING THE VACCINE. BOTH THE SOURCE PATIENT AND CLINICIAN RECEIVED POST EXPOSURE LAB WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76250 25 G X 1 IN. BD ECLIPSE¿ NEEDLE SAFETY ENGINEERED HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6140350

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention