BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE

    MDR report key: 9217976 · Received October 22, 2019

    Report

    Report Number
    8041187-2019-00837
    Event Type
    Malfunction
    Date Received
    October 22, 2019
    Date of Event
    September 21, 2019
    Report Date
    October 23, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057598
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, THE ROOT CAUSE OF THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE SAFETY GUARD DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305759 BATCH NO.: 9070996. IT WAS REPORTED THAT THE SAFETY GUARD DETACHED UPON USE. PR 2 OF 2: THIS PR IS FOR MEDWATCH FORM WITH PT ID# ENDING IN 911. PER MED WATCH REPORT: RN USING 25 G X 5/8 BD ECLIPSE NEEDLE. WHEN ACTIVATING SAFETY GUARD AFTER USE THE SAFETY GUARD DETACHED. NO INJURY.

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 7 OCTOBER, 2019. MEDWATCH FORM WITH PT ID# ENDING IN 911 REPORT SOURCE OTHER: MEDWATCH REPORT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD ECLIPSE¿ NEEDLE SAFETY GUARD DETACHED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305759. BATCH NO.: 9070996. IT WAS REPORTED THAT THE SAFETY GUARD DETACHED UPON USE. PR 2 OF 2: THIS PR IS FOR MEDWATCH FORM WITH PT ID# ENDING IN 911. PER MED WATCH REPORT: RN USING 25 G X 5/8 BD ECLIPSE NEEDLE. WHEN ACTIVATING SAFETY GUARD AFTER USE THE SAFETY GUARD DETACHED. NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015791 BD ECLIPSE¿ NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 9070996 30382903057598

    Patients

    Seq Age Sex Outcome Treatment
    1 0 DA Other