BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE ECLIPSE 25X1 RB

    MDR report key: 10795499 · Received November 5, 2020

    Report

    Report Number
    8041187-2020-00714
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    October 13, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: D.2. MEDICAL DEVICE CATALOG #: 305762 D.4. MEDICAL DEVICE EXPIRATION DATE: 2025-05-31 D.4. MEDICAL DEVICE LOT #: 0143249 H.4. DEVICE MANUFACTURE DATE: 2020-05-22.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: 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 NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305761 BATCH NO.: 0143249. IT WAS REPORTED THAT WHEN PULLING THE PINK SAFETY BACK IT SNAPPED OFF. THIS OCCURRED SEVERAL TIMES WITH DIFFERENT NURSES. THIS OCCURRED PRIOR TO USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305761; BATCH NO.: 0143249. IT WAS REPORTED THAT WHEN PULLING THE PINK SAFETY BACK IT SNAPPED OFF. THIS OCCURRED SEVERAL TIMES WITH DIFFERENT NURSES. THIS OCCURRED PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE LOT #: THE CUSTOMER PROVIDED LOT # 0143249. THIS DOES NOT MATCH THE CATALOG NUMBER PROVIDED. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE ECLIPSE 25X1 RB SAFETY MECHANISM DETACHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305761. BATCH NO.: 0143249. IT WAS REPORTED THAT WHEN PULLING THE PINK SAFETY BACK IT SNAPPED OFF. THIS OCCURRED SEVERAL TIMES WITH DIFFERENT NURSES. THIS OCCURRED PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254869 NEEDLE ECLIPSE 25X1 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 305761 0143249 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1