BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8290467 · Received January 30, 2019

    Report

    Report Number
    1213809-2019-00132
    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

    H.6. INVESTIGATION: 9 SAMPLES WERE RECEIVED FOR EVALUATION. THEY HAVE: INK RING, INK DOTS, PLUNGER DAMAGED, EMBEDDED BLACK SPECKS, BARREL SCRATCHED, AIR BUBBLE- BARREL, PLASTIC ADHERED TO THE PLUNGER/ INNER BARREL WALL THEREFORE FAILURE MODE IS VERIFIED. 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. 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. AIR BUBBLES ARE CAUSED WHEN VENTS ON MOLD PARTIALLY PLUGGED WITH PLASTIC GAS DISCHARGE PREVENTING/OBSTRUCTING PRIMARY VENT DISCHARGE OR MOLD MELT DISK PROBES PARTIALLY OBSTRUCTED WHICH CREATES A JETTING EFFECT IN THE PLASTIC FLOW. IN TURN, THIS CREATES HEAD AND UNEVEN FLOW THROUGH THE GATES AND CAUSES BUBBLES. 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. IT IS UNKNOWN HOW THE PLASTIC BECAME ADHERED TO THE PLUNGER / INNER BARREL WALL. THERE WAS NO DOCUMENTATION OF ISSUES FOR THE COMPLAINT OF BATCH #S 8023771, 8023788 DURING THE PRODUCTION RUNS. ADDITIONALLY FROM THE LOT# 8023788 THREE SUB LOTS WERE PRODUCED (EXTRA PRODUCTION DOCUMENTED AS OVERFLOW); SUB-LOT 8004891NO ISSUES FOR THE COMPLAINT WERE DOCUMENTED. SUB-LOT 8004893 MISSING PRINT ISSUES DOCUMENTED, PRODUCTS AFFECTED WERE SCRAPPED. SUB-LOT 8004898 INK RINGS ISSUES DOCUMENTED, PRODUCTS AFFECTED WERE SCRAPPED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TOTAL OF 182 BD LUER-LOK¿ SYRINGES HAD ISSUES RANGING FROM DAMAGED PLUNGERS, MISSING SCALE MARKINGS AND "BAD PRINT CONTAMINATION", AND "BLACK AND WHITE" FOREIGN MARKS. LOT #S 8023771 AND 8023788 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 #: 8023771, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2018-01-23. MEDICAL DEVICE LOT #: 8023788, MEDICAL DEVICE EXPIRATION DATE: 2023-01-31, DEVICE MANUFACTURE DATE: 2018-01-23. (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 182 BD LUER-LOK¿ SYRINGES HAD ISSUES RANGING FROM DAMAGED PLUNGERS, MISSING SCALE MARKINGS AND "BAD PRINT CONTAMINATION", AND "BLACK AND WHITE" FOREIGN MARKS. LOT #S 8023771 AND 8023788 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
    81174 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other