BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18784951 · Received February 26, 2024

    Report

    Report Number
    1213809-2024-00118
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    September 5, 2023
    Report Date
    September 19, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLES WERE RECEIVED AND INVESTIGATED UNDER PR (B)(4). TWO SAMPLES OF 1ML LUER-LOK SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES FROM BATCH 2192092 REGARDING ITEM 309628. BOTH SAMPLES WERE RECEIVED LOOSE, WITH ONE BARREL HAVING TWO AIR BUBBLES IN THE SIDE OF THE BARREL WALL. THE CONDITION OBSERVED DOES AFFECT FORM, FIT OR FUNCTION; THEREFORE, CONSIDERED ACCEPTABLE PER PRODUCT SPECIFICATION. THE OTHER SYRINGE HAD SKEWED SCALE CAUSING SLIPPED SCALE. THE CONDITIONS OBSERVED ARE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE/SLIPPED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2192092 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE MANUFACTURER INVESTIGATION CLOSED HAS BEEN USED FOR THIS FIELD. TWO LOOSE SAMPLES OF 1ML LUER-LOK SYRINGES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SYRINGE BARREL HAD TWO BUBBLES IN THE SIDE OF THE BARREL WALL. THE OBSERVED CONDITION DOES NOT AFFECT FORM, FIT, OR FUNCTION, SO THE CONDITION IS ACCEPTABLE PER PRODUCT SPECIFICATION. THE SECOND SYRINGE HAD A SKEWED SCALE. THIS CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309628, LOT 2192092. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 2192092 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT, AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THE SCALE MARKING DEFECT APPEARS TO BE OCCURRING AT OR BELOW ITS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM. RN, PROVIDED AN IV SET (2426-0007) THAT HAD THE SILASTIC SECTION OF THE TUBING SEPARATE FROM THE UPPER FITMENT. SHE STATED AN RL6 WAS SUBMITTED WEEKS AGO AND PROVIDED THE IV SET TO TIM HAUK. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629970 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2192092 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown