BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML LUER-LOK SYRINGE

    MDR report key: 8294385 · Received January 31, 2019

    Report

    Report Number
    1213809-2019-00136
    Event Type
    Malfunction
    Date Received
    January 31, 2019
    Date of Event
    January 10, 2019
    Report Date
    May 8, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096480
    PMA / PMN Number
    K941562
    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 1ML SYRINGES WERE RECEIVED AND EVALUATED FROM LOT NUMBER 8271675. TWO SYRINGES WERE OBSERVED TO HAVE SCRATCHES APPROXIMATELY 0.375" IN LENGTH BETWEEN THE 0.1ML AND 0.2ML MARKINGS. ONE SYRINGE HAD THE SCRATCH INSIDE THE GRAD LINE AND ONE HAD THE SCRATCH OUTSIDE THE GRAD LINES. ONE SYRINGE WAS OBSERVED TO HAVE AN IMPROPER FILL, SCALE MARKING ISSUE AT THE 0.6 AND 0.7 MARKINGS AS WELL AS THE "SINGLE USE ONLY". THREE LOOSE 1ML SYRINGES WERE RECEIVED AND EVALUATED FROM LOT NUMBER 8161661. ONE SYRINGE WAS OBSERVED TO HAVE A SWIRL OF BROWN EMBEDDED FOREIGN MATTER EXTENDING FROM THE 0.15ML TO THE 0.8ML MARKINGS. IT APPEARS TO BE BURNT PLASTIC AND IS LARGER THAN LEVEL 3 IN SIZE, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE SURFACE SCRATCHES THROUGH THE GRAD LINES EXTENDING FROM THE 0.2ML TO THE 0.5ML MARKINGS. THE SCRATCHES RESULTED IN MORE THAN HALF OF AT LEAST ONE GRAD LINE MISSING WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. ONE SYRINGE WAS OBSERVED TO HAVE A JAMMED STOPPER CONDITION AND A PLUNGER ROD BENT APPROXIMATELY 1" BELOW THE THUMB REST. NO SAMPLES/PHOTOS RECEIVED FOR LOT NUMBER 7321522. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POTENTIAL ROOT CAUSE IS ASSOCIATED WITH THE ASSEMBLY PROCESS FOR DAMAGED BARREL, JAMMED STOPPER, AND SCALE PERMANENCY. MARKING PROCESS FOR THE SCALE QUALITY, AND MOLDING PROCESS FOR THE EMBEDDED FOREIGN MATTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE 344 AFFECTED BD 1ML LUER-LOK¿ SYRINGES THAT HAD DAMAGE, MISSING PRINT, SCALE MARKING ERROR, AND FOREIGN MATTER.

    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 #: 8271675. MEDICAL DEVICE EXPIRATION DATE: 2023-09-30. DEVICE MANUFACTURE DATE: 2018-09-28. MEDICAL DEVICE LOT #: 8161661. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31. DEVICE MANUFACTURE DATE: 2018-06-10. MEDICAL DEVICE LOT #: 7321522. MEDICAL DEVICE EXPIRATION DATE: 2022-11-30. DEVICE MANUFACTURE DATE: 2017-11-17. (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 THERE WERE 344 AFFECTED BD 1ML LUER-LOK¿ SYRINGES THAT HAD DAMAGE, MISSING PRINT, SCALE MARKING ERROR, AND FOREIGN MATTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    85459 BD 1ML LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903096480

    Patients

    Seq Age Sex Outcome Treatment
    1 Other