BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19217550 · Received April 30, 2024

    Report

    Report Number
    1213809-2024-00263
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 15, 2024
    Report Date
    November 5, 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
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBER INCLUDES 3180021 AND OTHER EXPIRATION DATE INCLUDES 2028-06-30. 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 2023-06-29.

    Additional Manufacturer Narrative · 0

    TWO SAMPLES AND TWO PHOTOS OF 3 ML LL SYRINGES (P/N 309657 BATCH 3180021) WERE RECEIVED AND EVALUATED. THE FIRST PHOTO SHOWS TWO 3 ML SYRINGES IN WHAT APPEARS TO BE A FULLY SEALED PACKAGE EACH, VISIBLE FROM THE TRANSPARENT BOTTOM WEB. BOTH SYRINGES PRESENT AN INSECURE STOPPER. THE SECOND PHOTO SHOWS THE TOP WEB SLIP WITH ALL THE APPROPRIATE INFORMATION FOR A 3 ML LUER-LOK SYRINGE. ADDITIONALLY, THE TWO LOOSE SAMPLES WERE RECEIVED FULLY DISASSEMBLED, AND NO DEFECTS WERE PRESENT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THE POTENTIAL ROOT CAUSE OF THE DISTORTED STOPPER IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    MATERIAL# 309657 BATCH #3158207 #3180021. IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "UPON MIXING IVS WE NOTICED THE BLACK SYRINGE MEASUREMENT POINT IS DISLODGED IN TWO 3ML SYRINGES. SEE PICTURES FOR LOT AND EXPIRATION DATE." VERBATIM RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. UPON MIXING IVS WE NOTICED THE BLACK SYRINGE MEASUREMENT POINT IS DISLODGED IN TWO 3ML SYRINGES. SEE PICTURES FOR LOT AND EXPIRATION DATE. WE HAD ONE LAST WEEK THAT WAS MISSING THE BLACK RUBBER STOPPER. THE MISSING STOPPER WAS A 5 ML SYRINGE. LOT. 3346774 EXP. 11/30/28.

    Description of Event or Problem · 0

    ADDRESS AND CONTACT EMAIL UPDATED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2080952 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3158207 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown