BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE

    MDR report key: 13334035 · Received January 24, 2022

    Report

    Report Number
    8041187-2022-00030
    Event Type
    Malfunction
    Date Received
    January 24, 2022
    Date of Event
    January 3, 2022
    Report Date
    February 2, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057802
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: PISTON SYRINGE. MEDICAL DEVICE TYPE: FMF. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K941562 (SYRINGE). PMA / 510(K)#: K161170 (NEEDLE). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2022-01-27. H6: INVESTIGATION SUMMARY ONE PHOTO AND ONE SYRINGE SAMPLE WITH OPEN PACKAGING WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE SCALE MARKING WAS OBSERVED TO BE MISSING ON THE SYRINGE BARREL. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND OBSERVED A MISSING SCALE MARKING ON THE SYRINGE BARREL. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE PACKAGING LINE WAS REVIEWED AND THERE WAS NO STATION IN CONTACT WITH THE SCALE MARKING OF THE BARREL THAT COULD RESULT IN THE MISSING SCALE MARKING. AS THE SYRINGE PART IS FROM BD CANAAN, THE QUALITY TEAM AT BD CANAAN HAS COMPLETED A SUPPLEMENTAL INVESTIGATION. BASED ON THEIR INVESTIGATION, THE ROOT CAUSE HAS BEEN DETERMINED TO BE ASSOCIATED WITH THE MARKING PROCESS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCALE MISSING"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE HAD NO SCALE MARKINGS ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SCALE MISSING"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1063054 BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 1147722 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown