BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 12860910 · Received November 23, 2021

    Report

    Report Number
    1213809-2021-00779
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 26, 2021
    Report Date
    December 7, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE BOX CONTAINING ONE-HUNDRED AND EIGHTY-NINE 3ML SYRINGES (P/N 309657) SEALED IN BLISTERPAKS FROM BATCH #1181532 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. IT SHOULD BE NOTED THAT THERE WAS NO PLUNGER ROD ABNORMALITIES PRESENT THAT WOULD LEAD TO THE COMPLAINT DEFECT. IT IS UNCLEAR IN WHAT WAY THE SYRINGE WAS BEING USED THAT MAY HAVE LED TO THE PLUNGER ROD SNAPPING AS THE CUSTOMER REPORTED. SINCE THE SAMPLES DID NOT DISPLAY THE REPORTED CONDITION A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP DISPOSABLE SYRINGES' PLUNGERS BENT EASILY DURING USE, AND SOME BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE MENTIONED THAT THE PLUNGER BENDS AND SOMETIMES SNAPS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD LUER-LOK¿ TIP DISPOSABLE SYRINGES' PLUNGERS BENT EASILY DURING USE, AND SOME BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SHE MENTIONED THAT THE PLUNGER BENDS AND SOMETIMES SNAPS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759162 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 1181532 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown