BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE

    MDR report key: 14354952 · Received May 11, 2022

    Report

    Report Number
    8041187-2022-00246
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 20, 2022
    Report Date
    August 15, 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

    PMA / 510(K)#: K941562 (SYRINGE). 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

    H6: INVESTIGATION SUMMARY ONE PHOTO WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM OBSERVED THAT THE PLUNGER IS WITHDRAWN TO THE RETAINER RING AND THERE ARE SIGNS OF DISTORTION AT THE TOP STOPPER EDGE. 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 1ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THE QUALITY TEAM THERE HAS CONDUCTED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H10

    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: 20-JUL-2022 H.6. INVESTIGATION SUMMARY: ONE PHOTO AND ONE SAMPLE WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. FROM THE PHOTO, THE TEAM OBSERVED THAT THE PLUNGER IS WITHDRAWN TO THE RETAINER RING AND THERE ARE SIGNS OF DISTORTION AT THE TOP STOPPER EDGE. THE SAMPLE WAS SUBJECTED TO VISUAL INSPECTION AND THE TOP EDGE OF THE STOPPER IS OBSERVED TO BE DISTORTED DOWNWARDS INSIDE 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 1ML SYRINGE PART IS MANUFACTURED AT BD CANAAN AND THE QUALITY TEAM THERE HAS CONDUCTED A SUPPLEMENTAL INVESTIGATION ON THIS NONCONFORMANCE. A POTENTIAL ROOT CAUSE FOR THE JAMMED STOPPER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE HAD A DEFECTIVE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER. INCIDENT OCCUR: BEFORE USE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE HAD A DEFECTIVE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER. INCIDENT OCCUR: BEFORE USE."

    Description of Event or Problem · 0

    IT WAS REPORTED BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE HAD A DEFECTIVE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISTORTED STOPPER. INCIDENT OCCUR: BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693193 BD LUER-LOK¿ SYRINGE WITH BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305780 1237349 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown