BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB

    MDR report key: 10892067 · Received November 24, 2020

    Report

    Report Number
    8041187-2020-00773
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 27, 2020
    Report Date
    December 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057802
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-11-16. INVESTIGATION SUMMARY: TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. FROM THE PHOTOS, A PORTION OF THE SCALE MARKING FROM 0.1 ML TO 0.2 ML WERE OBSERVED TO BE MISSING ON THE SYRINGE BARREL. AN UNKNOWN LIQUID WAS OBSERVED TO FILL THE SYRINGE BARREL AND THE BARREL TIP WAS COVERED WITH AN UNKNOWN MATERIAL. THE SYRINGE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION, AND THE SCALE MARKING FROM 0.1 ML TO 0.2 ML WERE MISSING ON THE SYRINGE BARREL. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBERS WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE TUAS PACKAGING LINE WAS REVIEWED AND THERE IS NO CONTACT POINT WITH THE SCALE MARKING AREA (0.1ML TO 0.2ML) THAT COULD CAUSE THE MISSING SCALE MARKING. THE 1ML SYRINGE IS SUPPLIED BY BD CANNAN AND BD CANNAN HAD BEEN NOTIFIED OF THIS COMPLAINT. BASED ON BD CANAAN INVESTIGATION, POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT LIKELY DUE TO A JAM DURING ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB EXPERIENCED ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE SCALE IS BLURRED.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: BOTH FMI AND FMF ARE APPLICABLE FOR THIS DEVICE. PMA/510(K)#: TWO PMA/510(K)#S OF K161170 AND K941562 APPLY TO THIS DEVICE. 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 THE SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB EXPERIENCED ILLEGIBLE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE SCALE IS BLURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361927 SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE, PISTON SYRINGE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 0143236 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1