BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19038447 · Received April 3, 2024

    Report

    Report Number
    1213809-2024-00198
    Event Type
    Malfunction
    Date Received
    April 3, 2024
    Date of Event
    March 14, 2024
    Report Date
    August 22, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP REPORT FOR CORRECTION. THE EVENT/PRODUCT PROBLEM WAS INCORRECT IN THE INITIAL MDR. CORRECT EVENT/PRODUCT PROBLEM IS SILICONE VISIBLE ONE HUNDRED AND TWENTY-FIVE SAMPLES AND FOUR PHOTOS OF 3ML LUER-LOK SYRINGES WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO EXAMINE THE SAMPLES AND PHOTOS FROM BATCH 3121510 REGARDING ITEM 309657. ALL SAMPLES WERE RECEIVED IN SEALED PACKAGES IN STRIPS OF FIVE. ALL SAMPLES WERE INSPECTED AND 124 WERE FOUND TO BE ACCEPTABLE AND ONE WAS FOUND TO HAVE EXCESSIVE SILICONE. ALL PHOTOS FROM VARIOUS ANGLES SHOW THE PACKAGED SYRINGES IN A CLEAR BAG. THE REPORTED DEFECT COULD NOT BE OBSERVED IN ANY OF THE PHOTOS RECEIVED. FTIR ANALYSIS WAS INCONCLUSIVE AND SHOWED THE MOST LIKELY MATCHES TO BE CARDBOARD BOX OR COTTON SWAB, BOTH FOUND IN THE MANUFACTURING PLANT. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE REPORTED DEFECT WAS MANUFACTURED IN THE HOLDREGE PLANT WHICH NO LONGER MANUFACTURES THIS PRODUCT. THEREFORE, NO CORRECTIVE ACTIONS ARE REQUIRED FROM THE CANAAN MANUFACTURING PLANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3121510 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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    POST INVESTIGATION FINDINGS REVEALED THAT THE FOREIGN MATTER REPORTED WAS ACTUALLY SILICONE.

    Description of Event or Problem · 0

    MATERIAL#: (B)(4) BATCH#: UNKNOWN (PROVIDED BATCH# 3121510) IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAD A 3ML SYRINGE THAT HAD MOLD IN THE PACKAGING, LOT # 312510." ADDITIONAL INFORMATION PROVIDED ON 03/19/2024: 1.CAN YOU PLEASE PROVIDE CUSTOMER ADDRESS AND PHONE NUMBER? (B)(6) 2.WAS THERE IS ANY PICTURE OF THIS COMPLAINT? NO PICTURE 3. HOW WAS PROCEDURE COMPLETED? PROCEDURE FOR PATIENT WAS COMPLETED BY GETTING A DIFFERENT SYRINGE AND CHECKING THE LOT NUMBER AND SYRINGE BEFORE USE. 4. PLEASE PROVIDE FURTHER DETAILS? NURSE SAID SHE SAW SOMETHING ¿FUZZY¿ ON THE SYRINGE TIP AREA. IT FELL IN THE FLOOR AND SHE IMMEDIATELY GOT THE CHARGE NURSE TO TELL HER. THEY PULLED ALL OF THE LOT NUMBERS ASSOCIATED WITH THE FIRST SYRINGE ¿LOT 3121510¿ 5.WHEN WAS THIS NOTED? PRIOR TO USE OR DURING USE? NOTE PRIOR TO USE 6.PLEASE PROVIDE BATCH NUMBER? LOT 3121510.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76523 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3121510 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown