BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ 20 ML SYRINGE WITH NEEDLE

    MDR report key: 9261558 · Received October 31, 2019

    Report

    Report Number
    3002682307-2019-00583
    Event Type
    Malfunction
    Date Received
    October 31, 2019
    Date of Event
    October 12, 2019
    Report Date
    December 12, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAS BEEN PROVIDED WITH A PHOTO AND A SAMPLE FOR CATALOG 301948 LOT 1811239 TO INVESTIGATE FOR THIS RECORD. VISUAL EXAMINATION OF THE PHOTO AND SAMPLE REVEALED THAT THERE WAS NO CANNULA FIXED IN THE HUB OF THE NEEDLE. AS A RESULT, BD WAS ABLE TO VERIFY THE REPORTED ISSUE. BD CAN CONCLUDE THIS ISSUE HAPPENS DURING THE CANNULA ASSEMBLY PROCESS POSSIBLY BECAUSE OF SOME VISCOSITY VARIATION IN THE EPOXY. THIS RESULTED IN SOME INAPPROPRIATE EPOXY DOSAGE BY AN INCORRECT FIXING POSITION TO THE NEEDLE. THIS IS A VERY UNUSUAL CIRCUMSTANCE BECAUSE THE NEEDLES ARE 100% INSPECTED FOR PRESENCE OF EPOXY IN THE MANUFACTURING PROCESS. AFTER DISCUSSING WITH OUR MANUFACTURING TECHNICIANS, BD BELIEVES THAT THE REPORTED SAMPLE WAS NOT REJECTED AS EXPECTED BECAUSE OF THE PRESENCE OF EPOXY ON THE HUB WHAT WAS NOT CONSIDERED AS MISSING EPOXY BY THE CAMERA SYSTEM. DHR SHOWED NO INDICATION OF THE ALLEGED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE NEEDLE HAD PULLED OUT OF THE HUB WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2019, RECEIVED A REPORT FROM THE PURCHASING CENTER THAT THE NURSE WAS USING A 20ML SYRINGE PRODUCT FOUNDED THE NEEDLE PULLED OUT OF HUB AND COULD NOT BE USED NORMALLY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 THAT PRIOR TO USE IT WAS DISCOVERED THAT THE NEEDLE HAD PULLED OUT OF THE HUB WITH A BD¿ 20 ML SYRINGE WITH NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON (B)(6) 2019, RECEIVED A REPORT FROM THE PURCHASING CENTER THAT THE NURSE WAS USING A 20ML SYRINGE PRODUCT FOUNDED THE NEEDLE PULLED OUT OF HUB AND COULD NOT BE USED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1053488 BD¿ 20 ML SYRINGE WITH NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 1811239

    Patients

    Seq Age Sex Outcome Treatment
    1 Other