BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 10429405 · Received August 20, 2020

    Report

    Report Number
    8041187-2020-00505
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 31, 2020
    Report Date
    September 24, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    UDI-DI
    30382903057802
    PMA / PMN Number
    SEE H.10.
    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: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/12/2020. H.6. INVESTIGATION: TWO PHOTOS AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. DURING VISUAL INSPECTION OF THE SAMPLE, A MISSING SCALE MARKING, AN INK SMEAR ON THE SYRINGE BARREL, A DAMAGED BARREL, AND A BENT FLANGE WAS OBSERVED. THEREFORE, THE TEAM WAS ABLE TO CONFIRM THE CUSTOMER EXPERIENCE. 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 PACKAGING LINE WAS REVIEWED AND THERE IS NO CONTACT POINT WITH THE DAMAGED AREA ON THE BARREL AND NO PROCESS IN THE PACKAGING LINE THAT COULD HAVE BENT THE FLANGE. THE SAMPLE WAS SENT TO THE SUPPLIER SITE FOR FURTHER INVESTIGATION. THE POTENTIAL ROOT CAUSE FOR THESE NON-CONFORMANCES WAS DETERMINED TO BE ASSOCIATED WITH THE MARKING PROCESS. THERE WAS MOST LIKELY A JAM OR A MISTIMING AT THE MARKER WHICH CAUSED THE BARREL TO BE FED INCORRECTLY AND DAMAGED. A BENT FLANGE REJECTION MECHANISM HAS BEEN ADDED TO THIS MACHINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB WAS MISSING SCALE MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE WITHOUT SCALE."

    Additional Manufacturer Narrative · 1

    (B)(6). MULTIPLE 510K NUMBERS: K941562, K161170. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB WAS MISSING SCALE MARKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE WITHOUT SCALE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899460 SYRINGE 1ML LL W/NDL ECLIPSE 25X5/8 RB HYPODERMIC SINGLE LUMEN NEEDLE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 305780 0031617 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other