BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19580316 · Received June 21, 2024

    Report

    Report Number
    1213809-2024-00397
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 27, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    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

    MATERIAL: 309628 BATCH#: 3027085 IT WAS REPORTED BY THE CUSTOMER THAT THEY DID THE NORMAL PREPARATION ACCORDING TO THE PI AND THAT SHE DREW THE RECONSTITUTED SOLUTION INTO THE SYRINGE, WHICH WAS LEFT ON THE TRAY FOR THE DOCTOR TO ADMINISTER THE PRODUCT TO THE PATIENT. HOWEVER,IN WHEN THE DOCTOR WENT TO ADMINISTER THE PRODUCT, HE NOTICED THAT THERE WAS NO MORE SOLUTION INSIDE THE SYRINGE, PROBABLY DUE TO A LEAK. THE PRODUCT WAS NEVER ADMINISTERED TO ANY PATIENT." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE REPORT STATES, "JA IS A CERTIFIED OPHTHALMIC TECHNICIAN WHO CALLED TODAY TO REPORT AN ISSUE WITH IZERVAY. SHE SAYS THAT SHE DID THE NORMAL PREPARATION ACCORDING TO THE PI AND THAT SHE DREW THE RECONSTITUTED SOLUTION INTO THE SYRINGE, WHICH WAS LEFT ON THE TRAY FOR THE DOCTOR TO ADMINISTER THE PRODUCT TO THE PATIENT. HOWEVER, WHEN THE DOCTOR WENT TO ADMINISTER THE PRODUCT, HE NOTICED THAT THERE WAS NO MORE SOLUTION INSIDE THE SYRINGE, PROBABLY DUE TO A LEAK. THE PRODUCT WAS NEVER ADMINISTERED TO ANY PATIENT."

    Description of Event or Problem · 0

    MATERIAL: 309628. BATCH#: 3027085. IT WAS REPORTED THAT THE BD LUER-LOK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY DID THE NORMAL PREPARATION ACCORDING TO THE PI AND THAT SHE DREW THE RECONSTITUTED SOLUTION INTO THE SYRINGE, WHICH WAS LEFT ON THE TRAY FOR THE DOCTOR TO ADMINISTER THE PRODUCT TO THE PATIENT. HOWEVER,N WHEN THE DOCTOR WENT TO ADMINISTER THE PRODUCT, HE NOTICED THAT THERE WAS NO MORE SOLUTION INSIDE THE SYRINGE, PROBABLY DUE TO A LEAK. THE PRODUCT WAS NEVER ADMINISTERED TO ANY PATIENT." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THE REPORT STATES, "JA IS A CERTIFIED OPHTHALMIC TECHNICIAN WHO CALLED TODAY TO REPORT AN ISSUE WITH IZERVAY. SHE SAYS THAT SHE DID THE NORMAL PREPARATION ACCORDING TO THE PI AND THAT SHE DREW THE RECONSTITUTED SOLUTION INTO THE SYRINGE, WHICH WAS LEFT ON THE TRAY FOR THE DOCTOR TO ADMINISTER THE PRODUCT TO THE PATIENT. HOWEVER, WHEN THE DOCTOR WENT TO ADMINISTER THE PRODUCT, HE NOTICED THAT THERE WAS NO MORE SOLUTION INSIDE THE SYRINGE, PROBABLY DUE TO A LEAK. THE PRODUCT WAS NEVER ADMINISTERED TO ANY PATIENT." ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU SHARE ANY PHYSICAL SAMPLE OR PHOTO IF AVAILABLE FOR INVESTIGATION? NEITHER A RETURN SAMPLE OR PICTURES OF THE PRODUCT IN QUESTIONS ARE AVAILABLE AS THE HCP DISPOSED OF THE PRODUCT IN A SHARPS CONTAINER. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. THERE WAS NO ADVERSE EVENT OR INJURY REPORTED FOR THE PATIENT OR THE HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172962 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3027085 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown