BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE

    MDR report key: 8280490 · Received January 27, 2019

    Report

    Report Number
    1213809-2019-00113
    Event Type
    Malfunction
    Date Received
    January 27, 2019
    Date of Event
    January 10, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903010738
    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: THREE LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED FOR LOT NUMBER 8140548. IT WAS OBSERVED ONE SYRINGE HAD THREE SMALL BLACK EMBEDDED FOREIGN MATTER PARTICLES IN THE PLUNGER ROD. THEY APPEARED TO BE BURNT PLASTIC AND WERE SMALLER THAN LEVEL 3 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. THE SYRINGE ALSO HAD A ROLLED SCALE WHERE THE SCALE WAS PRINTED AT AN ANGLE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. TWO SYRINGES WERE OBSERVED TO HAVE SKEWED SCALES THAT WERE CUT OFF BELOW THE 1.5ML MARKING AND WERE BOTH REJECTABLE PER PRODUCT SPECIFICATION. THREE LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED FOR LOT NUMBER 8240729. IT WAS OBSERVED ONE SYRINGE HAD A SKEWED SCALE THAT WAS CUT OFF BELOW THE 1.5ML MARKING AND WAS REJECTABLE PER PRODUCT SPECIFICATION. THE SYRINGE ALSO HAD A SCRATCH AND A DEFORMATION NEAR THE TOP OF THE BARREL. ONE SYRINGE WAS OBSERVED TO HAVE A SMALL BLACK STRIPE OF FOREIGN MATTER OUTSIDE THE FLUID PATH ON THE LUER OF THE BARREL. IT APPEARS TO BE INK AND WAS LARGER THAN LEVEL 4 IN SIZE AND WAS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE SIGNIFICANT DAMAGE TO THE BARREL AND PLUNGER ROD. IT APPEARS THE SYRINGE WAS CRUSHED AND HAD DIAGONAL INDENTATIONS OUTSIDE THE GRAD LINES EXTENDING FROM THE1.5ML TO 3ML GRAD LINES. THE FLANGE WAS ALSO BENT AND A PLUNGER ROD RIB NEAR THE THUMB REST WAS CRACKED. ONE LOOSE 3ML SYRINGE WAS RECEIVED AND EVALUATED FOR LOT NUMBER 8098580. IT WAS OBSERVED THERE WAS A SMALL BLACK EMBEDDED FOREIGN MATTER PARTICLE IN THE LUER OF THE BARREL. IT APPEARED TO BE BURNT PLASTIC AND WAS SMALLER THAN LEVEL 3 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. THREE LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED FOR LOT NUMBER 8054540. IT WAS OBSERVED ONE OF THE SYRINGES CONTAINED MULTIPLE BROWN EMBEDDED FOREIGN MATTER PARTICLES IN THE LUER OF THE BARREL. THEY APPEARED TO BE BURNT PLASTIC AND ARE ALL SMALLER THAN LEVEL 3 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE SCRATCHES THAT CAUSED FLAT SPOT IN THE BARREL EXTENDING FROM THE LUER UP TO THE 1ML MARKING. ONE SYRINGE WAS OBSERVED TO HAVE A CIRCLE OF MISSING PRINT INSIDE THE GRAD LINES FROM THE 2ML TO THE 2.5ML MARKING WITH MORE THAN HALF OF THE "2" MISSING AND IS REJECTABLE PER PRODUCT SPECIFICATION TWO LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED FOR LOT NUMBER 8020529. IT WAS OBSERVED ONE OF THE SYRINGES CONTAINED A SMALL BLACK EMBEDDED FOREIGN MATTER PARTICLE IN THE LUER OF THE BARREL. IT APPEARED TO BE BURNT PLASTIC AND WAS SMALLER THAN LEVEL 3 IN SIZE WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE A DEEP SCRATCH EXTENDING FROM THE LUER TO THE 1ML MARK OUTSIDE THE GRAD LINES. TWO LOOSE 3ML SYRINGES WERE RECEIVED AND EVALUATED FOR LOT NUMBER 8073753. IT WAS OBSERVED ONE SYRINGE CONTAINED A SMALL BLACK FOREIGN MATTER PARTICLE OUTSIDE THE FLUID PATH ON THE BOTTOM OF THE PLUNGER ROD. IT APPEARED TO BE A FIBER AND WAS SMALLER THAN LEVEL 3 IN SIZE, WHICH IS ACCEPTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE SOME SURFACE SCRATCHES ON THE LUER OF THE BARREL THAT APPEARED TO BE COSMETIC IN NATURE WITH NO FUNCTION DEFECT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE ASSEMBLY PROCESS FOR DAMAGED BARREL, AND MARKING PROCESS FOR THE FOREIGN MATTER OUTSIDE THE FLUID PATH AND SKEWED SCALE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WAS DAMAGED, HAD FOREIGN MATTER, AND SCALE MARKING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8140548. MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2018-05-20. MEDICAL DEVICE LOT #: 8240729. MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. DEVICE MANUFACTURE DATE: 2018-08-28. MEDICAL DEVICE LOT #: 8098580. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-04-08. MEDICAL DEVICE LOT #: 8054540. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-02-23. MEDICAL DEVICE LOT #: 8020529. MEDICAL DEVICE EXPIRATION DATE: 2022-12-31. DEVICE MANUFACTURE DATE: 2018-01-20. MEDICAL DEVICE LOT #: 8073753. MEDICAL DEVICE EXPIRATION DATE: 2023-02-28. DEVICE MANUFACTURE DATE: 2018-03-14. (B)(6). A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD LUER-LOK¿ SYRINGE WAS DAMAGED, HAD FOREIGN MATTER, AND SCALE MARKING ISSUES. NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73151 BD LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903010738

    Patients

    Seq Age Sex Outcome Treatment
    1 Other