BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19282639 · Received May 9, 2024

    Report

    Report Number
    1213809-2024-00282
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 24, 2024
    Report Date
    November 13, 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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    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.

    Description of Event or Problem · 0

    MATERIAL# 309657 BATCH# 4053863 IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "HI, WE HAVE 3ML BD PLASTIPAK LEUR LOCK SYRINGES WHERE THE BLACK RUBBER PLUNGER IS UNEVEN SO NOT SURE HOW ACCURATE DOSES DRAWN UP WOULD BE. PRODUCT# 309657, WITH LOT NUMBER OF 4053863 AND EXP 1-31-29. THANKS" VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ADDITIONAL INFORMATION RECEIVED ON 04/29/2024: 1. KINDLY PROVIDE THE DATE OF EVENT? WAS DISCOVERED LAST WEEK. SO 4/24 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? YES- I HAVE 2 IN MY OFFICE. YOU HAVE WRONG ADDRESS ABOVE. THAT IS THE ADDRESS FOR (B)(6) HOSPITAL. CORRECT ADDRESS IS BELOW. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122777 BD LUER-LOK SYRINGE, PISTON FMF BECTON DICKINSON MEDICAL SYSTEMS 4053863 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown