BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LS

    MDR report key: 18415597 · Received December 28, 2023

    Report

    Report Number
    2243072-2023-02253
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    December 1, 2023
    Report Date
    January 19, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENT CONTROL THERE IS VISUAL INSPECTION FOR EXCESSIVE / NO SILICONE AND QA OUTGOING INSPECTION THERE IS PLUNGER BREAKOUT AND SUSTAINING FORCE TO CHECK FOR TIGHTNESS. DUE TO NO SAMPLE, NO PHOTO WAS RETURNED, ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINT WILL BE MONITORED AND REOPENED IF SAMPLE IS RETURNED.

    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

    ONE OF OUR ANESTHETIST ADVISED TODAY THAT DURING AN EYE INJECTION WITH A 5ML SYRINGE FROM BD WAS VERY STIFF THE PLUNGER WAS AND HARD TO PULL AND PUSH. HE THEN CHANGED SYRINGE TO ANOTHER BRAND AND FOUND THAT IT WAS THE SYRINGE AND NOT THE EYE PRESSURE. WE THEN PROCEED TO OPEN ANOTHER BD SYRINGE TO DIS COVER THAT THE Y WERE VERY STIFF AND HARD TO PULL AND PUSH THE PLUNGER AND COMPARE D TO ANOTHER BRAND. REF: 302130. BATCH LOT: 2141756. MANUFACTURE DATE : 2022-06. EXPIRY DATE: 2027-05.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 5ML LS PLUNGER MOVEMENT WAS DIFFICULT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR ANESTHETIST ADVISED TODAY THAT DURING AN EYE INJECTION WITH A 5ML SYRINGE FROM BD WAS VERY STIFF THE PLUNGER WAS AND HARD TO PULL AND PUSH. HE THEN CHANGED SYRINGE TO ANOTHER BRAND AND FOUND THAT IT WAS THE SYRINGE AND NOT THE EYE PRESSURE. WE THEN PROCEED TO OPEN ANOTHER BD SYRINGE TO DIS COVER THAT THE Y WERE VERY STIFF AND HARD TO PULL AND PUSH THE PLUNGER AND COMPARE D TO ANOTHER BRAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1400403 BD SYRINGE 5ML LS SYRINGE FMF BECTON DICKINSON 2141756

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown