BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK LUER-LOK

    MDR report key: 22425611 · Received July 7, 2025

    Report

    Report Number
    1213809-2025-00458
    Event Type
    Malfunction
    Date Received
    July 7, 2025
    Date of Event
    June 18, 2025
    Report Date
    July 30, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903033935
    PMA / PMN Number
    K974006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - LABEL CONTENT INCORRECT. ONE THOUSAND TWENTY-THREE SAMPLES OF 10ML TWINPAK SYRINGES (MATERIAL 303393) FROM BATCH 5065846 WERE EVALUATED. ALL SAMPLES ARRIVED IN SEALED PACKAGES WITHOUT BOX CARTONS. AMONG THEM, THREE PACKAGES CONTAINED 3ML SYRINGES, WHICH ARE NOT RELEVANT TO THE REPORTED COMPLAINT, AND ONE PACKAGE CONTAINED A CONFORMING 10ML SYRINGE WITH NO DEFECTS. THE REMAINING ONE THOUSAND NINETEEN PACKAGES CONTAINED 10ML SYRINGES BUT WERE INCORRECTLY LABELED WITH 5ML TOP WEB PACKAGING. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE INCORRECT TOP WEB DEFECT IS ASSOCIATED WITH THE PACKAGING PROCESS. A CORRECTIVE AND PREVENTIVE ACTION (CAPA) WILL BE INITIATED TO ADDRESS THE ISSUE AND PREVENT RECURRENCE. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5065846. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL W/TWINPAK DEVICE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 303393. BATCH#: 5065846. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE #: (B)(4). HOSPITAL COMPLAINT REFERENCE #: (B)(4). CAT# OF PRODUCT BEING COMPLAINED: BD303393 DESCRIPTION OF PRODUCT: SYRINGE 10CC W/CANNULA ST INTLINK 100EA/BX 4BX/CA. LOT OR S/N: (B)(6) COMPLAINT CATEGORY: LABELLING ISSUE. REPORTABLE: NO. INCIDENT DATE: (B)(6) 2025. HOSPITAL COMPLAINT REFERENCE #: (B)(4) DETAILS OF COMPLAINT (REPORTED ISSUE): "XX CAME IN BOXES THAT SAY THEY ARE 10ML SYRINGES, THE PACKAGING OF THE SYRINGES SAYS THEY ARE 5ML SYRINGES, AND THE SYRINGE INSIDE THE PACKAGING IS A 10ML". PLEASE NOTE: INCIDENT DATE & QUANTITY OF PRODUCT AFFECTED IS UNKNOWN. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: A FEW TIMES. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? UNKNOWN. QTY AFFECTED: 1 BX. SAMPLES AVAILABLE? YES. IS CUSTOMER REQUESTING AN RGA? NO. RETURN QTY: QTY SAMPLES: 1 BX.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356667 INTERLINK LUER-LOK NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5065846 00382903033935

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown