BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 18893771 · Received March 13, 2024

    Report

    Report Number
    1213809-2024-00164
    Event Type
    Malfunction
    Date Received
    March 13, 2024
    Date of Event
    February 2, 2024
    Report Date
    May 30, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    K951254
    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

    IT WAS REPORTED THAT THE BD SAFETY-LOK HAD LEAKAGE AT LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE WAS SECURELY ON THE SYRINGE, AND THE MAJORITY OF THE VACCINE LEAKED OUT THE CONNECTION BETWEEN THE TWO." WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF#(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: (B)(4). PRODUCT DESCRIPTION: NEEDLE HYPO 25 X 5/8IN SAFETY GLIDE SUB Q BX/50 P42 . LOT/SERIAL #: (B)(6). EXPIRY DATE: 2028-01-31. PROBLEM INFORMATION THE NEEDLE WAS SECURELY ON THE SYRINGE, AND THE MAJORITY OF THE VACCINE LEAKED OUT THE CONNECTION BETWEEN THE TWO. OCCURRENCES: 1 EACH. SAMPLE INFORMATION INCIDENT SAMPLES: 1 EACH. REPRESENTATIVE SAMPLES: 0. NO ADVERSE EVENT REPORTED.

    Description of Event or Problem · 0

    MATERIAL#: 305901 LOT#: 3034676. IT WAS REPORTED BY THE CUSTOMER THAT THE NEEDLE WAS SECURELY ON THE SYRINGE, AND THE MAJORITY OF THE VACCINE LEAKED OUT THE CONNECTION BETWEEN THE TWO. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF# (B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: PRODUCT PROBLEM REPORT: PRODUCT INFORMATION, PRODUCT CODE: 305901, PRODUCT DESCRIPTION: NEEDLE HYPO 25 X 5/8IN SAFETY GLIDE SUB Q BX/50 P42, LOT/SERIAL #: (B)(6), EXPIRY DATE: 2028-01-31. PROBLEM INFORMATION: THE NEEDLE WAS SECURELY ON THE SYRINGE, AND THE MAJORITY OF THE VACCINE LEAKED OUT THE CONNECTION BETWEEN THE TWO. OCCURRENCES: 1 EACH. SAMPLE INFORMATION: INCIDENT SAMPLES: 1 EACH. REPRESENTATIVE SAMPLES: 0. NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185589 BD SAFETY-LOK SAFETYGLIDE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 3034676

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown