BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 12110895 · Received July 2, 2021

    Report

    Report Number
    1024879-2021-00449
    Event Type
    Injury
    Date Received
    July 2, 2021
    Date of Event
    June 8, 2021
    Report Date
    August 11, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT((BATCH NUMBER PROVIDED IS INCORRECT); THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE DEVICE EXPERIENCED SAFETY SHIELD FAILURE ¿ E.G. SHIELD BREAKS OFF FROM NEEDLE. THE NEEDLE NOT RETRACTING (ONE OCCURRENCE RESULTED IN A NEEDLE STICK). THE EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: COMPLAINT CATEGORY: DAMAGED / BROKEN. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): THE NEEDLE NOT RETRACTING (ONE OCCURRENCE RESULTED IN A NEEDLE STICK). THE CUSTOMER WANTS TO RETURN 350 EA COMPLAINT NOTICED: DURING / AFTER USE PATIENT INJURY: NO QTY AFFECTED: 2 EA.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. (BATCH: 0314466 DOES NOT EXIST FOR MATERIAL NUMBER: 368607.). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE, THE DEVICE EXPERIENCED SAFETY SHIELD FAILURE ¿ E.G. SHIELD BREAKS OFF FROM NEEDLE. THE NEEDLE NOT RETRACTING (ONE OCCURRENCE RESULTED IN A NEEDLE STICK). THE EVENT OCCURRED TWICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: COMPLAINT CATEGORY: DAMAGED / BROKEN. HOSPITAL COMPLAINT REFERENCE #: DETAILS OF COMPLAINT (REPORTED ISSUE): THE NEEDLE NOT RETRACTING (ONE OCCURRENCE RESULTED IN A NEEDLE STICK). THE CUSTOMER WANTS TO RETURN. 350 EA. COMPLAINT NOTICED: DURING / AFTER USE. PATIENT INJURY: NO. QTY AFFECTED: 2 EA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1007945 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 0314466 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other