BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20996900 · Received December 21, 2024

    Report

    Report Number
    1213809-2024-00983
    Event Type
    Malfunction
    Date Received
    December 21, 2024
    Date of Event
    November 25, 2024
    Report Date
    February 21, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED TWO SYRINGES WERE FOUND LEAKING UNDER THE PLUNGER AND TWO SYRINGES HAD DARK INK SPOTS. TO AID IN THE INVESTIGATION, FOUR LOOSE SAMPLES AND SIX PHOTOS OF 10ML LUER LOK SYRINGES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE TESTED FOR LEAKAGE AND THERE WAS NO LEAKAGE OBSERVED. TWO SAMPLES HAVE A BLACK DOT CIRCLED IN BLACK MARKER: ONE ON THE PLUNGER ROD AND ONE ON THE SYRINGE BARREL. THE PHOTOS SHOW ONE LOOSE SYRINGE FILLED WITH AN UNKNOWN CLEAR FLUID. TWO PHOTOS SHOW THE FOREIGN MATTER ON THE PLUNGER AS OBSERVED IN THE SAMPLE RECEIVED. THE OTHER FOUR PHOTOS SHOW THE SYRINGE FROM VARIOUS ANGLES WITH NO DEFECTS OBSERVED. THE REPORTED DEFECT FOR LEAKAGE WAS NOT IDENTIFIED IN THE PHOTOS OR SAMPLES RECEIVED. THE FOREIGN MATTER OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE MOLDING PROCESS. THE FOREIGN MATTER IS MOST LIKELY EMBEDDED DEGRADED PLASTIC THAT OCCURS AT THE STARTUP OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. THIS DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309605, POSSIBLE LOTS 4088618 ,3152762 ,3152757, 3324404, 3312338, 3324402, 4110189, 3312339, 3306030, 4058224 AND 4079242. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED PER REQUIREMENTS WITH NO QUALITY NOTIFICATIONS RELATED TO THE DEFECT REPORTED. THE LOTS WERE INSPECTED AND ACCEPTED BASED ON OUR INSPECTION CONTROL PLAN AND APPROVED FOR SHIPMENT. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL #: 309605, BATCH#: UNKNOWN. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. DURING COMPOUNDING LOT #20241125-2FF6AD TWO SYRINGES WERE FOUND LEAKING UNDER THE PLUNGER AND 2 WITH DARK INK SPOTS. PRODUCT#: 309605. ADDITIONAL INFORMATION PROVIDED: 1. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE. USE BEING COMPOUNDING. NO PATIENT INVOLVED. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MM-YYYY? (B)(6) 2024 3. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? I¿M NOT SURE OF THE LOT NUMBER. BELOW ARE ALL THE LOT #S THAT WERE USED IN THE COMPOUNDED BATCH (POTENTIAL LOT 4088618, 3152762, 3152757, 3324404, 3312338, 3324402, 4110189, 3312339, 3306030, 4058224, 4079242).

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628362 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS INCORRECT ENTRY 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown