BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8290441 · Received January 30, 2019

    Report

    Report Number
    1213809-2019-00131
    Event Type
    Malfunction
    Date Received
    January 30, 2019
    Date of Event
    January 10, 2019
    Report Date
    February 28, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    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: 42 SAMPLES WERE RECEIVED FOR EVALUATION. THEY HAVE SCALE MARKING ISSUES, PLUNGER ROD RIB DAMAGED, INK DOTS, RUB MARKS, EMBEDDED BLACK SPECKS, DEFORMED BARREL, BARREL SCRATCHED, INK RING, LUER TIP DAMAGED, ROLLED STOPPER, BURNT FLANGE, THEREFORE FAILURE MODES ARE CONFIRMED. 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. LIKE RUBMARKS, SCRATCHES CAN BE CAUSED BY A BARREL OR PLUNGER ROD GETTING CAUGHT IN THE ASSEMBLY MACHINERY AND MAKING CONTACT WITH OTHER SYRINGES. DEPENDING ON THE LOCATION OR ANGLE OF STUCK PART, IT CAN EITHER CAUSE A RUBMARK ACROSS A BROADER SURFACE OR A NARROW SCRATCH ON THE SIDE OF THE BARREL. 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. INK RINGS ARE GENERATED DURING THE GRADUATION SCALE PRINTING PROCESS. INK RINGS ARE CAUSED BY A DAMAGED DOCTOR BLADE. THE DOCTOR BLADE WIPES EXCESS INK OFF THE PRINT ETCHING WHICH TRANSFERS THE GRADUATION SCALE PATTERN ONTO THE PRINTING PAD. WHEN THE BLADE IS DAMAGED, IT WILL NOT WIPE THE EXCESS INK OFF OF THE ETCHING CAUSING A BLACK LINE TO BE PRINTED ON THE BARREL. 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. BURNS CAN BE CAUSED WHEN THERE IS BLOCKAGE IN THE MOLD VENTS/ GATES WHICH CAN CAUSE BURNS ON THE FLANGE OF THE SYRINGE DURING MOLDING PROCESS. THE DAMAGE TO THE TIP IS LIKELY A BROKEN PIN IN THE MOLD. THIS PIN IS WHAT THE TIP OF THE BARREL IS MOLDED AROUND, AND IF BROKEN CAN CAUSE THE TIP TO APPEAR AS IF IT WERE SHEARED OFF. ROLLED STOPPERS CAN OCCUR INTERMITTENTLY DURING ASSEMBLY OF THE SYRINGE WHEN THE PLUNGER ROD AND STOPPER SUBASSEMBLY ARE PRESSED INTO THE SYRINGE BARREL. A MISALIGNMENT BETWEEN THE BARREL AND SUBASSEMBLY CAN CAUSE THE ROLLED STOPPER. THE DAMAGED PLUNGER ROD RIB WAS 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. ROOT CAUSE FOR THE DEFORMED BARREL IS UNKNOWN. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #S 7206506, 8060847, 8066852, 8201667, 8227913, 8110976, 8110978, 8110979 DURING THE PRODUCTION RUNS. THERE WAS DOCUMENTATION OF ISSUES FOR THE COMPLAINT BATCH# 8201667 FOR SMEARED PRINT. PRODUCT AFFECTED WAS SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TOTAL OF 2,924 BD LUER-LOK¿ SYRINGES HAD ISSUES RANGING FROM DAMAGED PLUNGERS, MISSING SCALE MARKINGS, AND "BLACK AND WHITE" FOREIGN MARKS. LOT #S 8201667, 8227913, 8201666, 8227913, 8110979, 8110976, 8110978, 7206506, 8060847, AND 8066852 WERE REPORTED TO HAVE BEEN INVOLVED IN THE EVENTS, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED IN EACH LOT.

    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 #: 8201667. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-07-20. MEDICAL DEVICE LOT #: 8227913. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-15. MEDICAL DEVICE LOT #: 8201666. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. DEVICE MANUFACTURE DATE: 2018-07-20. MEDICAL DEVICE LOT #: 8227913. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-15. MEDICAL DEVICE LOT #: 8110979. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-20. MEDICAL DEVICE LOT #: 8110976. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-20. MEDICAL DEVICE LOT #: 8110978. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-04-20. MEDICAL DEVICE LOT #: 7206506. MEDICAL DEVICE EXPIRATION DATE: 2022-07-31. DEVICE MANUFACTURE DATE: 2017-07-25. MEDICAL DEVICE LOT #: 8060847. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-01. MEDICAL DEVICE LOT #: 8066852. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-03-07. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TOTAL OF 2,924 BD LUER-LOK¿ SYRINGES HAD ISSUES RANGING FROM DAMAGED PLUNGERS, MISSING SCALE MARKINGS, AND "BLACK AND WHITE" FOREIGN MARKS. LOT #S 8201667, 8227913, 8201666, 8227913, 8110979, 8110976, 8110978, 7206506, 8060847, AND 8066852 WERE REPORTED TO HAVE BEEN INVOLVED IN THE EVENTS, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED IN EACH LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81154 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other