BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ TIP SYRINGE

    MDR report key: 16705138 · Received April 8, 2023

    Report

    Report Number
    1213809-2023-00336
    Event Type
    Malfunction
    Date Received
    April 8, 2023
    Date of Event
    February 16, 2023
    Report Date
    May 3, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOURTEEN SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED. NINE SAMPLES WERE OBSERVED TO HAVE SLIGHT INK RINGS PRESENT NEAR THE 2ML GRAD LINES AND AROUND NEAR THE MID-POINT OF THE BARREL. FOUR SAMPLES HAVE MINOR PRINT IMPERFECTIONS ON THE MARKED SCALE IN VARIOUS AREAS OF THE PRINTED SCALE AND BD LOGO. THE INK RINGS AND MINOR IMPERFECTIONS DID NOT AFFECT FORM, FIT, LEGIBILITY, OR FUNCTION OF THE SYRINGES AND WERE ACCEPTABLE PER PRODUCT SPECIFICATIONS. ONE SAMPLE HAVE MISSING ALMOST ONE ENTIRE GRAD LINE WITH A LARGE CHUNK OF THE NEIGHBORING ABOVE LINE WAS ALSO MISSING. THE OBSERVED CONDITION WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT CONDITION IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2030421. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD NO SCALE MARKINGS ON IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER IS REPORTING OIL STAINS, UNCLEAR SCALE LINES, AND SURFACE SCRATCHES UPON THEIR INSPECTION... NO PATIENT HARM INVOLVED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ TIP SYRINGE HAD NO SCALE MARKINGS ON IT. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. "CUSTOMER IS REPORTING OIL STAINS, UNCLEAR SCALE LINES, AND SURFACE SCRATCHES UPON THEIR INSPECTION. NO PATIENT HARM INVOLVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1729891 BD LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 2030421

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown