BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 18682850 · Received February 11, 2024

    Report

    Report Number
    1213809-2024-00073
    Event Type
    Malfunction
    Date Received
    February 11, 2024
    Date of Event
    January 25, 2024
    Report Date
    August 23, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    FIFTEEN SAMPLES AND TWO PHOTOS OF 10ML LUER-LOK SYRINGES (P/N - 302995) BATCH 3251093 WERE RECEIVED AND EVALUATED. THREE STRIPS OF 5 SYRINGES WERE IN SEALED PACKAGES WITH ALL THE PERFORATIONS MISSING. BOTH PHOTOS SHOW TWO PACKAGED SYRINGES, WITH ONE IMAGE SHOWING THE TOP WEB SIDE AND THE OTHER IMAGE SHOWING THE BOTTOM WEB SIDE, AND BOTH PHOTOS SHOW THE PERFORATIONS MISSING AS DESCRIBED ABOVE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE UNCUT PACKAGES DEFECT IS RELATED TO THE PACKAGING PROCESS. IT IS LIKELY THE LEVER THAT CONTROLS THE AIRFLOW TO THE SLITTER STATION WAS INADVERTENTLY HIT TO THE ¿OFF¿ POSITION FOR A SHORT AMOUNT OF TIME EITHER DURING A JAM OR FOR A WEB (PACKAGING MATERIAL) CHANGE BEFORE BEING CORRECTED IN PROCESS. THE SLITTER STATION WAS EXAMINED WHERE THE PACKAGES ARE PERFORATED ON THE MACHINE. THE SLITTERS THAT PERFORATE THE PACKAGE PRIOR TO BOX LOADING ARE DRIVEN PNEUMATICALLY AND NOT ELECTRONICALLY. A LEVER THAT CONTROLS THE AIR FLOW TO THE SLITTER STATION WAS NOTED TO BE IN A POSITION THAT ALLOWS IT TO BE ACCIDENTALLY HIT DURING ROUTINE OPERATION/JAM CLEARING OR DURING WEB (PACKAGING MATERIAL) CHANGES. THE LEVER THAT CONTROLS THE AIR FLOW TO THE SLITTER STATION WAS RELOCATED TO A MORE ERGONOMICALLY FRIENDLY LOCATION ON THE MACHINE THAT WORKS TO MITIGATE THE RISK FOR ACCIDENTAL ACTIVATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3251093 THAT SHOWED NO OTHER 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 RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 PACKAGING HAD POOR PERFORATION/SLIT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD SYRINGES THAT CAME WITHOUT ANY PERFORATIONS ON THEM, THEREFORE THEY CAN'T BE TORN APART. PICS ATTACHED." VERBATIM: INJURIES OR ADVERSE EVENT: NO. ITEM: 302995. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: BD SYRINGES THAT CAME WITHOUT ANY PERFORATIONS ON THEM, THEREFORE THEY CAN'T BE TORN APART. PICS ATTACHED. CUSTOMER DISPOSITION REQUEST: REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82835 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3251093 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown