BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER LOK SYRINGE

    MDR report key: 8250535 · Received January 15, 2019

    Report

    Report Number
    1911916-2019-00031
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 28, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 77 SAMPLES WERE RECEIVED FOR EVALUATION. THEY HAVE SCALE PRINTING ISSUES, EMBEDDED BLACK SPECKS, DAMAGE PARTS, LOOSE PIECE OF PLASTIC, RUB MARKS, INK DOTS. INK DOTS CAN OCCUR AFTER THE GRADUATION SCALE PRINTING PROCESS. DURING TRANSPORT BETWEEN THE PRINTING, ASSEMBLY, AND PACKAGING PROCESSES, SYRINGES CAN MAKE CONTACT WITH EACH OTHER. IT IS POSSIBLE THAT DURING CONTACT, INK FROM THE GRADUATION SCALE CAN TRANSFER BETWEEN SYRINGES CAUSING DOTS OF INK. A RUBMARK IS LIKELY CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE ASSEMBLY MACHINERY AND MAKING CONTACT WITH SYRINGES AS THEY ARE BEING PROCESSED. THIS CAN RUB THE PRINT ON THE SYRINGE AND CAUSE IT TO BE MISSING IN CERTAIN LOCATIONS. EMBEDDED FOREIGN MATTER CAN OCCUR AT THE STARTUP OF AN INJECTION MOLD/PRESS OR INTERMITTENTLY DURING THE INJECTION MOLDING PROCESS. DEGRADED RESIN INHERENTLY BUILDS UP IN THE BARREL AND HOT-RUNNER SYSTEM OF THE MOLD AND PRESS. THE DEGRADED RESIN CAN BREAK LOOSE AND BE MOLDED INTO COMPONENTS. THIS IS A COSMETIC DEFECT ONLY AND DOES NOT AFFECT THE INTEGRITY OF THE SYRINGE. A BROKEN OR DAMAGED PLUNGER ROD IS LIKELY CAUSED BY A JAM ON THE ASSEMBLY MACHINE. IF THERE IS A MISTIMING BETWEEN THE ASSEMBLY OF THE PLUNGER ROD TO THE BARREL, IT COULD CASE THE PLUNGER ROD TO BREAK AND/OR BE DAMAGED. THIS WOULD APPLY TO THE LOOSE PIECE OF PLASTIC AS WELL. MISSING PRINT IS CONSIDERED ACCEPTABLE IF UNDER 50% OF ANY GIVEN ITEM (NUMBER, LETTER, OR GRADUATION LINE) IS MISSING AND STILL LEGIBLE. A RUBMARK IS LIKELY CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE ASSEMBLY MACHINERY AND MAKING CONTACT WITH SYRINGES AS THEY ARE BEING PROCESSED. THIS CAN RUB THE PRINT ON THE SYRINGE AND CAUSE IT TO BE MISSING IN CERTAIN LOCATIONS. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #S 7227677, 7227678, 7296592, 7324620, 7324621, 7353622, 7353624, 7353633, 7353648, 7324620, 7352585, 7353589, 8023782, 8023805, 8079538, 8079539 DURING THE PRODUCTION RUNS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT MULTIPLE BD¿ LUER LOK SYRINGES HAD FOREIGN MATTER CONTAMINATION, PRODUCT DAMAGE, AND SCALE MARKING ISSUES PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7227678. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2017-08-15. MEDICAL DEVICE LOT #: 8079538. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-20. MEDICAL DEVICE LOT #: 8023805. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2018-01-23. MEDICAL DEVICE LOT #: 7227677. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2017-08-15. MEDICAL DEVICE LOT #: 7227678. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2017-08-15. MEDICAL DEVICE LOT #: 8023782. MEDICAL DEVICE EXPIRATION DATE: 2023-01-31. DEVICE MANUFACTURE DATE: 2018-01-23. MEDICAL DEVICE LOT #: 7353653. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2017-12-19. MEDICAL DEVICE LOT #: 8079539. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-20. MEDICAL DEVICE LOT #: 7353585. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2017-12-19. MEDICAL DEVICE LOT #: 7353633. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2017-12-19. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MULTIPLE BD¿ LUER LOK SYRINGES HAD FOREIGN MATTER CONTAMINATION, PRODUCT DAMAGE, AND SCALE MARKING ISSUES PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44308 BD LUER LOK SYRINGE SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other