BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20435185 · Received October 12, 2024

    Report

    Report Number
    1213809-2024-00702
    Event Type
    Malfunction
    Date Received
    October 12, 2024
    Date of Event
    September 16, 2024
    Report Date
    January 25, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    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

    D.4. OTHER LOT NUMBER INCLUDES 4040291 AND OTHER EXPIRATION DATE INCLUDES 2029-01-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-02-09.

    Additional Manufacturer Narrative · 0

    10838609 - SUPPLEMENTAL MDR - FOREIGN MATTER A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309659 AND LOT NUMBERS 4116530 AND 4040291. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, FOUR HUNDRED (400) SYRINGE SAMPLES AND ONE (1) PICTURE SAMPLE WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PICTURE SHOWED ONE (1) SYRINGE IN AN UNSEALED PACKAGE WITH AN UNKNOWN YELLOW FLUID INSIDE OF THE SYRINGE. NO FURTHER CONCLUSIONS WERE POSSIBLE BASED ON THE PICTURE ALONE. ALL OF THE PHYSICAL SAMPLES RECEIVED WERE WITHIN SEALED PACKAGES WITH ONE (1) SEALED BOX CARTON OF LOT 4116530 AND ANOTHER SEALED BOX CARTON OF LOT 4040291. NO DEFECTS WERE OBSERVED IN ANY OF THE PROVIDED PHYSICAL SAMPLES. BASED ON THE INVESTIGATION RESULTS, WE WERE UNABLE TO DETERMINE AN EXACT CAUSE FOR THE REPORTED INCIDENT. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY.

    Description of Event or Problem · 0

    MATERIAL#: 309659. BATCH#:4040291, 3031943. 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. CALLER CONFIRMS HE IS A DISTRIBUTOR WHO ORDERS SYRINGE 309659 (LOT 4040291 AND LOT 3031943) FOR A CUSTOMER. CALLER STATES THE CUSTOMER SENT AN EMAIL STATING THAT THEY ARE HAVING ISSUES WITH THE SYRINGE. CALLER STATES THE PRIMER FLUID IS TURNING YELLOW. ADDITIONAL INFORMATION PROVIDED: PLEASE PROVIDE DATE OF EVENT. ¿ MONDAY 16 SEP 2024. COULD YOU PLEASE PROVIDE NUMBER OF OCCURRENCES THAT ARE OBSERVED RECENTLY? - THE FIRST TWO SYRINGE USED PRESENT THE CONDITION, THEN WAS REPEAT WITH ONE SYRINGE OF EACH BATCH AND PRESENT THE SAME CONDITION. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? ¿ THE SYRINGE WAS NOT USED IN THE MANUFACTURING PROCESS, SINCE THE CONDITION WAS IDENTIFIED BEFORE USED. 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? WAS THIS ISSUE TRACED BEFORE USE OR DURING DRAW OF LIQUID INTO SYRINGE? ¿ WAS IDENTIFIED WHEN THE DRAW THE LIQUID INTO SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342511 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4116530 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown