BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14136319 · Received April 18, 2022

    Report

    Report Number
    8041187-2022-00197
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 24, 2022
    Report Date
    May 31, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057802
    PMA / PMN Number
    K161170
    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 DEVICE NAMES/TYPES AND 510K NUMBERS REPORTED TO BE INVOLVED. ADDITIONAL INFORMATION BELOW: MEDICAL DEVICE TYPE: FMF. COMMON DEVICE NAME: PISTON SYRINGE. PMA / 510(K)#: K941562. 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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 14-APR-2022. H.6. INVESTIGATION: ONE PHOTO AND ONE SYRINGE SAMPLE IN OPEN PACKAGING WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM OBSERVED THAT THE PLUNGER IS WITHDRAWN TO THE SCALE MARKING OF 0.65 ML AND THERE ARE SIGNS OF DISTORTION AT THE TOP STOPPER EDGE. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND THE TEAM OBSERVED THAT THE TOP EDGE OF THE STOPPER IS DISTORTED DOWNWARDS INSIDE THE SYRINGE BARREL. UPON PULLING OUT THE PLUNGER FROM THE SYRINGE BARREL, IT WAS OBSERVED CLEARLY THAT THE TOP OF THE STOPPER IS NOT FLAT BUT DISTORTED AT ONE END. 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 1 ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THE BD CANAAN QUALITY TEAM HAS PERFORMED A SUPPLEMENTAL INVESTIGATION. THE POTENTIAL ROOT CAUSE OF THIS JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER IN THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STOPPER IN THE BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE WAS DEFECTIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627289 BD ECLIPSE¿ NEEDLE WITH DETACHABLE BD LUER-LOK¿ SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 1237349 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown