BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD® LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 17925881 · Received October 12, 2023

    Report

    Report Number
    2243072-2023-01835
    Event Type
    Malfunction
    Date Received
    October 12, 2023
    Date of Event
    September 25, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096269
    PMA / PMN Number
    K110771
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) - FOLLOW UP MDR FOR DEVICE EVALUATION. TWO SAMPLES OF 1ML LUER-SLIP SYRINGES WITH 25X5/8¿ NEEDLES ATTACHED WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE SAMPLES FROM LOT #3060191 REGARDING ITEM #309626. BOTH SAMPLES WERE RECEIVED IN SEALED PACKAGES WITH ALL APPLICABLE PRODUCT INFORMATION ON THE TOP WEB. BOTH SAMPLES HAD NO DEFECTS. THE CONDITIONS OBSERVED ARE ACCEPTABLE PER PRODUCT SPECIFICATION. BASED UPON WHAT WAS REPORTED, THE CONSUMER ASSUMES THIS TO BE A SAFETYGLIDE NEEDLE. HOWEVER, THIS PRODUCT CODE AND NEEDLE ARE NOT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 3060191 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE HEALTH CARE PROVIDER WAS USING BD® LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE, THEY SUSTAINED A NEEDLE STICK INJURY. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: DETAILS OF COMPLAINT (REPORTED ISSUE): ITEMS RECEIVED DID NOT HAVE SAFETY GLIDES. A STAFF MEMBER DID GET A NEEDLE STICK INJURY BECAUSE IT WASN'T A SAFETY NEEDLE LIKE IT SAYS ON OUR WEBSITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1312722 BD® LUER SLIP TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096269

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other