BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19008422 · Received March 29, 2024

    Report

    Report Number
    1213809-2024-00186
    Event Type
    Malfunction
    Date Received
    March 29, 2024
    Date of Event
    March 1, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    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

    ONE HUNDRED AND SIXTEEN SAMPLES OF 5ML LUER-LOK SYRINGES (P/N - 309646) WERE RECEIVED AND EVALUATED. EIGHT INDIVIDUAL BAGS EACH CONTAINING A BAG OF SEALED PACKAGES FROM A DIFFERENT BATCH; CONSISTING OF 75 SAMPLES FROM BATCH 0175566, 24 SAMPLES FROM BATCH 1181080, 4 SAMPLES FROM 7324720, 4 SAMPLES FROM BATCH 8267569, 3 SAMPLES FROM BATCH 9344915, 3 SAMPLES FROM BATCH 7194570, 2 SAMPLES FROM BATCH 7086527, AND 1 SAMPLE FROM BATCH 6026822. ALL SAMPLES WERE FOUND TO HAVE NO OIL OR EXCESSIVE SILICONE DEFECTS AND ACCEPTABLE. FTIR ANALYSIS TESTING WAS PERFORMED AND CONFIRMED THE SUBSTANCE TO BE SILICONE USED IN THE MANUFACTURING PROCESS. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCHES 1181080, 0175566, 9344915 ARE CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THE SYRINGES FROM BATCHES, 8267569, 7324720, 7194570, 7086527, AND 6026822 HAVE BEEN EXPIRED SINCE 09/30/23, 10/31/22. 06/30/22, 03/31/22, AND 01/31/21 RESPECTIVELY. BD DOES NOT MAKE CLAIMS OF THE EFFICACY OF EXPIRED PRODUCT. A DEVICE HISTORY RECORD REVIEW IS NOT REQUIRED DUE TO THE COMPLAINT BEING FOR THE DESIGN OF THE PRODUCT AND NOT A TRUE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FM ON THE PLUNGER WAS ADVISED THAT IT WAS AN OIL RESIDUE." REF: (B)(4) LOT: MULTIPLE. ISSUE: FM ON THE PLUNGER WAS ADVISED THAT IT WAS AN OIL RESIDUE NO PT HARM. SAMPLE: YES. DATE OF EVENT: 01MAR2024.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2241309 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown