BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML E/T PRECISE

    MDR report key: 10155270 · Received June 15, 2020

    Report

    Report Number
    8041187-2020-00335
    Event Type
    Malfunction
    Date Received
    June 15, 2020
    Date of Event
    May 22, 2020
    Report Date
    July 2, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 6/9/2020 H.6. INVESTIGATION: ONE PHOTO AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FOREIGN MATTER WAS OBSERVED ON THE SYRINGE TIP, VERIFYING 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 MOLDING OPERATION AND ASSEMBLY OPERATION WAS REVIEWED. THE MOLDED BARREL IS TRANSFERRED FROM THE MOLDING OPERATION TO THE ASSEMBLY OPERATION VIA AN OVERHEAD CONVEYOR. THE FOREIGN MATTER COULD HAVE TRANSFERRED TO THE SYRINGE TIP DURING THIS PROCESS IF THE PRODUCT STUCK TO THE OVERHEAD CONVEYOR GAP BETWEEN THE BELT AND SIDE GUIDE. THE OVERHEAD CONVEYOR HAS BEEN MODIFIED TO PREVENT STUCK BARRELS AND RUBBING AGAINST THE SIDE GUIDE. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 20ML E/T PRECISE EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR THEATRE ANAESTHETISTS FOUND ONE OF THE 20ML PRECISE SYRINGES THAT HAS DIRT AROUND THE TIP OF THE SYRINGE, LUCKILY IT WAS DISCOVERED IN TIME! THE ITEM HAS BEEN RETURNED TO MY OFFICE, THE COMPLETE BATCH HAS BEEN TAKEN OUT OF THEATRE. WE HAVE ISOLATED THE STOCK OF THE SAME BATCH NUMBER IN OUR STORES (11 BOXES).

    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 THE SYRINGE 20ML E/T PRECISE EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONE OF OUR THEATRE ANAESTHETISTS FOUND ONE OF THE 20ML PRECISE SYRINGES THAT HAS DIRT AROUND THE TIP OF THE SYRINGE, LUCKILY IT WAS DISCOVERED IN TIME! THE ITEM HAS BEEN RETURNED TO MY OFFICE, THE COMPLETE BATCH HAS BEEN TAKEN OUT OF THEATRE. WE HAVE ISOLATED THE STOCK OF THE SAME BATCH NUMBER IN OUR STORES (11 BOXES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619929 SYRINGE 20ML E/T PRECISE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) 9296085

    Patients

    Seq Age Sex Outcome Treatment
    1 Other