BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LS PRECISE

    MDR report key: 10280725 · Received July 15, 2020

    Report

    Report Number
    8041187-2020-00412
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    June 25, 2020
    Report Date
    August 7, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. VISUAL INSPECTION OF THE PHOTO SHOWED A LIQUID INSIDE THE BARREL, CONFIRMING 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. WHILE THE TEAM WAS ABLE TO CONFIRM THE CUSTOMER EXPERIENCE, BECAUSE THERE WAS NO PHYSICAL SAMPLES RETURNED TO DETERMINE THE FOREIGN MATTER TYPE, THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 20ML LS PRECISE EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A VISCIOUS/OILY LIQUID IN THE 20ML SYRINGE..

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: AN INVALID LOT # WAS PROVIDED AS 9120880. IF A CORRECTED LOT # IS PROVIDED THE INFORMATION WILL BE UPDATED. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYRINGE 20ML LS PRECISE EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A VISCIOUS/OILY LIQUID IN THE 20ML SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738918 SYRINGE 20ML LS PRECISE SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other