BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ STERILE CONVENIENCE TRAYS W/ 10ML LUER-LOK TIP SYRINGES

    MDR report key: 17901659 · Received October 9, 2023

    Report

    Report Number
    1213809-2023-01111
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 25, 2023
    Report Date
    February 1, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED A WHITE BUILD UP WAS IN A 10ML SYRINGE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE COMPLETED. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309605, LOT 3150806. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 3150806 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. 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 EMERGIN.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ STERILE CONVENIENCE TRAYS W/ 10ML LUER-LOK TIP SYRINGES FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WANTED TO ADD THAT WE HAVE ANOTHER EXAMPLE OF THIS SAME ISSUE. THERE WAS WHITE BUILD UP (SAME AS THIS ORIGINAL COMPLAINT) FOUND IN A 10 ML SYRINGE. IT WAS IN THE 10 ML CONVENIENCE PACK WITH LOT#3150806.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711127 BD¿ STERILE CONVENIENCE TRAYS W/ 10ML LUER-LOK TIP SYRINGES PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3150806 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown