BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19326395 · Received May 15, 2024

    Report

    Report Number
    1213809-2024-00293
    Event Type
    Malfunction
    Date Received
    May 15, 2024
    Date of Event
    April 25, 2024
    Report Date
    May 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    MATERIAL # 309657. LOT # 3237170. IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS DEFECTIVE/DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "RUBBER ON SYRINGE PLUNGER LOOKS DEFORMED." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RUBBER ON SYRINGE PLUNGER LOOKS DEFORMED. DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP 3ML. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 309657. SERIAL OR LOT NUMBER: 3237170. DEVICE EXPIRY DATE (YYYY-MM-DD): 2028-07-31. SUPPLIER: (B)(6). SUPPLIER CATALOGUE NUMBER: (B)(6). WAS THE DEVICE RETAINED? NO.

    Description of Event or Problem · 0

    MATERIAL # 309657 LOT # 3237170 IT WAS REPORTED BY CUSTOMER THAT RUBBER ON SYRINGE PLUNGER LOOKS DEFORMED. RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RUBBER ON SYRINGE PLUNGER LOOKS DEFORMED. DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP 3ML MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 309657 SERIAL OR LOT NUMBER: 3237170 DEVICE EXPIRY DATE (YYYY-MM-DD): 2028-07-31 SUPPLIER: (B)(4) SUPPLIER CATALOGUE NUMBER: 308-309657 WAS THE DEVICE RETAINED? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634372 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3237170 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown