BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 10197028 · Received June 25, 2020

    Report

    Report Number
    1213809-2020-00419
    Event Type
    Malfunction
    Date Received
    June 25, 2020
    Date of Event
    June 4, 2020
    Report Date
    July 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: EIGHT PHOTOS AND EIGHT LOOSE 1ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED IN SEVEN PHOTOS AND SEVEN PHYSICAL SAMPLES, THERE WAS A SMALL PERPENDICULAR SCRATCH OUTSIDE THE GRAD LINES APPROXIMATELY 3/16" IN LENGTH AT THE 0.14ML MARKING. ONE SYRINGE HAD MINOR SCUFF MARKS OUTSIDE THE GRAD LINES. IN ALL EIGHT SYRINGES THE SCRATCHES WERE ACCEPTABLE PER PRODUCT SPECIFICATION. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9232833 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. A POTENTIAL ROOT CAUSE FOR THE SCRATCHED BARREL DEFECT IS LIKELY ASSOCIATED WITH THE ASSEMBLY PROCESS. SINCE THE DEFECTS OBSERVED ARE WITHIN THE ACCEPTABLE LIMITS, NO CORRECTIVE ACTIONS ARE NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SCRATCHES WERE FOUND ON THE BD SYRINGE LUER-LOK¿ TIP DURING USE AT THE "0.13-0.15 MARK". THIS OCCURRED WITH 8 SEPARATE SYRINGES, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCRATCHES OBSERVED AT THE 0.13-0.15 MARK. SIGNIFICANT SCRATCHES OBSERVED AT THE 0.13-0.15 MARK DURING COMPOUNDING. THESE SYRINGES WERE REJECTED FOR USE."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SCRATCHES WERE FOUND ON THE BD SYRINGE LUER-LOK¿ TIP DURING USE AT THE "0.13-0.15 MARK." THIS OCCURRED WITH 8 SEPARATE SYRINGES, BUT THE DATES ARE UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCRATCHES OBSERVED AT THE 0.13-0.15 MARK. SIGNIFICANT SCRATCHES OBSERVED AT THE 0.13-0.15 MARK DURING COMPOUNDING. THESE SYRINGES WERE REJECTED FOR USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    657537 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309628 9232833 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other