BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE NON STERILE 50ML LL

    MDR report key: 18667020 · Received February 8, 2024

    Report

    Report Number
    3003152976-2024-00064
    Event Type
    Malfunction
    Date Received
    February 8, 2024
    Date of Event
    November 20, 2023
    Report Date
    March 20, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903002233
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW FOR LOT 2212082 DID NOT REVEAL ANY ANNOTATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS RELATED TO THIS INCIDENT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. SHOULD YOU EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT, EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE.

    Additional Manufacturer Narrative · 0

    (B)(4) : INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    PRODUCT LEAKAGE THROUGH THE PLUNGER WHEN REMOVING THE VELETRI ADDITIONAL INFO: THERE WAS NO ABNORMALITY SEEN IN THE PLUNGER, THE PERSON CONCERNED DOESN'T RECALL ANY DEFORMATION OR OTHER. PATIENT USE: THE SYRINGE IS INSERTED INTO A HOMECARE SET FOR INFUSION. VELETRI, A DRUG, IS PLACED IN THE 50ML SYRINGE. THIS INFUSION IS USED TO TREAT A LUNG DISEASE CALLED "PULMONARY ARTERIAL HYPERTENSION". PATIENT RISK : SHOULD TREATMENT BE INTERRUPTED AND/OR POSTPONED? LOSS OF MEDICATION. IN THE CONTEXT OF HOME CARE: HOW DOES THE PATIENT GO ABOUT CARRYING OUT OR CONTINUING HIS TREATMENT? HE NEEDS ADDITIONAL PRODUCT AND/OR A PRESCRIPTION AND/OR SOMEONE TO RETURN TO THE PHARMACY. NO PHOTO OR SAMPLE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2240831 SYRINGE NON STERILE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2212082 50382903002233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown