BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP DISPOSABLE SYRINGE

    MDR report key: 16019109 · Received December 20, 2022

    Report

    Report Number
    1213809-2022-01287
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    December 1, 2022
    Report Date
    January 21, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096572
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THERE WERE VISIBLE AND PALPABLE PINHOLE DEFECTS IN THE PAPER STERILE PACKAGING. AS A SAMPLE WAS NOT RETURNED A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD, PRODUCTION DATABASE AND TECHNICIAN LOGS REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309657, LOT 1140707. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS OR NOTES RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD LUER-LOK¿ TIP DISPOSABLE SYRINGES HAD PINHOLES IN THEIR UNIT PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VISIBLE AND PALPABLE PINHOLE DEFECTS IN THE PAPER STERILE PACKAGING OF 3 ML SYRINGES. ONE OPEN PACKAGE, 3 UNUSED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD LUER-LOK¿ TIP DISPOSABLE SYRINGES HAD PINHOLES IN THEIR UNIT PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VISIBLE AND PALPABLE PINHOLE DEFECTS IN THE PAPER STERILE PACKAGING OF 3 ML SYRINGES. ONE OPEN PACKAGE, 3 UNUSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455678 BD LUER-LOK¿ TIP DISPOSABLE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1140707 00382903096572

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown