BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 12637135 · Received October 14, 2021

    Report

    Report Number
    1213809-2021-00712
    Event Type
    Malfunction
    Date Received
    October 14, 2021
    Date of Event
    September 17, 2021
    Report Date
    November 11, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096498
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 10/28/2021. H6: INVESTIGATION: SIX PHOTOS AND ONE 5ML SYRINGE IN A SEALED PACKAGE, CONFIRMED TO BE FROM BATCH #1123113 (P/N 309649), WERE RECEIVED. THE PHYSICAL SAMPLE MATCHED THE SAMPLE IN THE PHOTOS. THE SAMPLE WAS VISUALLY EVALUATED. THE BARREL WAS OBSERVED TO HAVE NUMEROUS BLACK EMBEDDED FOREIGN MATTER PARTICLES IN THE FLANGE, BARREL WALL, LUER COLLAR, AND TIP. WHICH IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE PARTICLES WERE FOUND THROUGHOUT MOST OF THE BARREL¿S SURFACE. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. 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. H3 OTHER TEXT: SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 5ML SYRINGE LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED CONTAMINATED LUERLOCK SYRINGE 5 ML.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 THE BD 5ML SYRINGE LUER-LOK¿ TIP EXPERIENCED FOREIGN MATTER IN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER RECEIVED CONTAMINATED LUERLOCK SYRINGE 5 ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1532154 BD 5ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309649 1123113 30382903096498

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown