BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21060532 · Received January 2, 2025

    Report

    Report Number
    1213809-2024-01017
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    November 25, 2024
    Report Date
    January 22, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION.

    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

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 309632, BATCH#: 4066411. IT WAS REPORTED THAT THE BD LUER-LOK WAS MIXED PRODUCT / LOTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. DURING ROUTINE USE OF SP.0171 (I.E., MTN 5250_8) STOCK, UNIDENTIFIED VENDOR MATERIAL (5ML SYRINGE, 21G X 1.5" TW) WAS FOUND WITH MANUFACTURER PART NUMBER: 309633, LOT: 4011811 IN MTN 5250_8 INVENTORY SUPPLY. INVESTIGATION ON 25NOV2024 DISCOVERED 298 INDIVIDUAL SYRINGE UNITS COLLECTED AND SUBSEQUENTLY QUARANTINED FROM THE ACCEPTED LOT. HOWEVER, THE ORIGINAL SHIPMENT WAS FOUND IN ACCORDANCE WITH CERTIFICATE AND SPECIFICATION REQUIREMENTS. FURTHERMORE, 510 UNITS WERE INSPECTED AND FOUND ACCEPTABLE AT TIME OF RECEIPT AND THE MATERIAL WAS NOT IDENTIFIED AT THE TIME OF MATERIAL INSPECTION TO DETERMINE THE TRUE SOURCE OF 309633. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO ADVERSE EVENTS OR SERIOUS INJURY TO REPORT AT THIS TIME. 2. PLEASE RECONFIRM TOTAL NUMBER OF OCCURRENCES. UNITS FOUND IN INVENTORY: (B)(4) INDIVIDUALLY WRAPPED SYRINGE, REF: 309633, LOT: 4011811. 3. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? THIS IS THE MATERIAL THAT WAS NOT ORDERED BUT FOUND WITHIN INVENTORY OF MATERIAL THAT WAS ORDERED WITH REF: 309632 4. GIVEN MATERIAL NUMBER#: 309633 IS NOT MATCHING THE LOT#: 4066411. SO PLEASE CONFIRM THE MATERIAL NUMBER AND LOT NUMBER. FURTHER, CONFIRMATION OF MATERIAL RECEIVED BUT NOT ORDERED, REF: 309633, LOT: 4011811. THE LOT IS INCORRECT AS LOT: 4066411 CORRESPONDS TO REF: 309632, THE MATERIAL THAT WAS ORIGINALLY ORDERED AND WITHIN SOFIE MATERIAL ACCEPTANCE RECORDS. ADDITIONAL INFO: A TOTAL OF (5) SAMPLES OF REF: 309633, LOT: 4011811 WAS SENT OUT YESTERDAY, MONDAY DECEMBER 16TH WITH THE SHIPPING LABEL PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115362 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4066411 30382903096320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown