BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X1 RB

    MDR report key: 20992874 · Received December 20, 2024

    Report

    Report Number
    2243072-2024-01251
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 21, 2024
    Report Date
    April 3, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OUR QUALITY ENGINEER INSPECTED THE SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF NEEDLE CLOGGED/ BLOCKED WAS CONFIRMED UPON INSPECTION OF THE SAMPLE. ANALYSIS OF THE SAMPLE SHOWED IT TO BE CLOGGED DUE TO FOREIGN MATTER. THE FOREIGN MATTER COULD NOT BE EXTRACTED FROM THE RETURNED SAMPLE. THE ROOT CAUSE COULD NOT BE ESTABLISHED AS THE FOREIGN MATTER COULD NOT BE EXTRACTED FOR ADDITIONAL TESTING. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # GEN2500107) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: ECLIPSE. DEVICE FAILURE: NEEDLE DAMAGED / DEFECTIVE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL#: 305761, BATCH NUMBER#: 3294600. IT WAS REPORTED BY CUSTOMER THAT ENCOUNTERED THIS SITUATION TWICE WHERE WE NOTICED THAT THE PRODUCT BD ECLIPSE SAFETY NEEDLE 1 INCH LOT # 3294600 EXP 2028-10-31 THE NEEDLE WAS DEFECTIVE. ONCE THE NEEDLE WAS ATTACHED TO THE SYRINGE IT WAS IMPOSSIBLE TO PUSH THE CONTENTS OF THE SYRINGE (VACCINE) OUT OF THE NEEDLE, SEEMS AS IF THE NEEDLE IS BLOCKED. BOTH NURSES CHANGED THE NEEDLE AND USED THE SAME BATCH NUMBER, AND THIS TIME WORKED SO IT'S SPORADIC. WE ENCOUNTERED THIS SITUATION IN TWO DIFFERENT BOXES OF THE SAME BATCH NUMBER. WE HAVE SEVERAL BOXES OF THIS PRODUCT HERE AT PUBLIC HEALTH. FORTUNATELY, NO INCIDENT OCCURRED. VERBATIM#: NOUS AVONS RENCONTRÉ À DEUX REPRISES CETTE SITUATION OÙ NOUS AVONS REMARQUÉ QUE LE PRODUIT BD ECLIPSE AIGUILLE SÉCURITAIRE 1 POUCE # LOT 3294600 EXP 2028-10-31 L¿AIGUILLE ÉTAIT DÉFECTUEUSE. UNE FOIS L¿AIGUILLE ATTACHÉE À LA SERINGUE IL ÉTAIT IMPOSSIBLE DE POUSSER LE CONTENU DE LA SERINGUE (VACCIN) DE L¿AIGUILLE, SEMBLE COMME SI L¿AIGUILLE EST BOUCHÉE. LES DEUX INFIRMIÈRES ONT CHANGÉ L¿AIGUILLE ET A UTILISÉ LE MÊME NUMÉRO DE LOT ET CETTE FOIS-CI A FONCTIONNÉ DONC C¿EST SPORADIQUE. NOUS AVONS RENCONTRÉ CETTE SITUATION DANS DEUX BOITES DIFFÉRENTES DE CE MÊME NUMÉRO DE LOT. NOUS AVONS PLUSIEURS BOITES DE CE PRODUIT ICI À LA SANTÉ PUBLIQUE. HEUREUSEMENT AUCUN INCIDENT NE S¿EST PRODUIT. TRANSLATE VERSION: WE HAVE ENCOUNTERED THIS SITUATION TWICE WHERE WE NOTICED THAT THE PRODUCT BD ECLIPSE SAFETY NEEDLE 1 INCH LOT # 3294600 EXP 2028-10-31 THE NEEDLE WAS DEFECTIVE. ONCE THE NEEDLE WAS ATTACHED TO THE SYRINGE IT WAS IMPOSSIBLE TO PUSH THE CONTENTS OF THE SYRINGE (VACCINE) OUT OF THE NEEDLE, SEEMS AS IF THE NEEDLE IS BLOCKED. BOTH NURSES CHANGED THE NEEDLE AND USED THE SAME BATCH NUMBER AND THIS TIME WORKED SO IT'S SPORADIC. WE ENCOUNTERED THIS SITUATION IN TWO DIFFERENT BOXES OF THE SAME BATCH NUMBER. WE HAVE SEVERAL BOXES OF THIS PRODUCT HERE AT PUBLIC HEALTH. FORTUNATELY NO INCIDENT OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1 RB HAD A NEEDLE DEFECT AND NEEDLE CLOGGED / BLOCKED. IT WAS REPORTED BY CUSTOMER THAT ENCOUNTERED THIS SITUATION TWICE WHERE WE NOTICED THAT THE PRODUCT BD ECLIPSE SAFETY NEEDLE 1 INCH LOT#: 3294600, EXP 2028-10-31 THE NEEDLE WAS DEFECTIVE. ONCE THE NEEDLE WAS ATTACHED TO THE SYRINGE IT WAS IMPOSSIBLE TO PUSH THE CONTENTS OF THE SYRINGE (VACCINE) OUT OF THE NEEDLE, SEEMS AS IF THE NEEDLE IS BLOCKED. BOTH NURSES CHANGED THE NEEDLE AND USED THE SAME BATCH NUMBER, AND THIS TIME WORKED SO IT'S SPORADIC. WE ENCOUNTERED THIS SITUATION IN TWO DIFFERENT BOXES OF THE SAME BATCH NUMBER. WE HAVE SEVERAL BOXES OF THIS PRODUCT HERE AT PUBLIC HEALTH. FORTUNATELY, NO INCIDENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2381267 BD NEEDLE ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON 3294600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown