BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    MDR report key: 14147778 · Received April 19, 2022

    Report

    Report Number
    1024879-2022-00229
    Event Type
    Injury
    Date Received
    April 19, 2022
    Date of Event
    April 5, 2022
    Report Date
    May 10, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN . 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL: YES. D9: RETURNED TO MANUFACTURER ON: 21-APR-2022. H6: INVESTIGATION SUMMARY: BD RECEIVED 12 SAMPLES FROM 5 DIFFERENT LOT NUMBERS (1327838, 2017189, 2041702, 2061612, 2041701) FOR INVESTIGATION. THE LOT NUMBER OF THE DEVICE INVOLVED WITH THE NEEDLE STICK IS UNKNOWN. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WAS NOT OBSERVED. IN ADDITION, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE LOT NUMBERS OF THE SAMPLES RECEIVED SHOWED THAT ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THERE WAS NEEDLE STICK INJURY - POST USE AND SAFETY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED A NEEDLE STICK OCCURRED. "WE HAD ANOTHER NEEDLE STICK WITH BD VACUTAINER 21G 1-1/4¿ THIS MORNING. THE STICK OCCURRED WHEN THE PHLEBOTOMIST FINGER SLIPPED TO THE SIDE. NOT FORWARD. THE EMPLOYEE SAID THAT THE SAFETY DEVICE WENT TO THE SIDE AND SHE POKED HERSELF". D.1. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER D.2. MEDICAL DEVICE CATALOG#: 368650. D.5. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.5. PMA / 510(K)#: K982541.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS NEEDLE STICK INJURY - POST USE AND SAFETY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED A NEEDLE STICK OCCURRED. "WE HAD ANOTHER NEEDLE STICK WITH BD VACUTAINER 21G 1-1/4¿ THIS MORNING. THE STICK OCCURRED WHEN THE PHLEBOTOMIST FINGER SLIPPED TO THE SIDE. NOT FORWARD. THE EMPLOYEE SAID THAT THE SAFETY DEVICE WENT TO THE SIDE AND SHE POKED HERSELF".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THERE WAS NEEDLE STICK INJURY - POST USE AND SAFETY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED A NEEDLE STICK OCCURRED. "WE HAD ANOTHER NEEDLE STICK WITH BD VACUTAINER 21G 1-1/4¿ THIS MORNING. THE STICK OCCURRED WHEN THE PHLEBOTOMIST FINGER SLIPPED TO THE SIDE. NOT FORWARD. THE EMPLOYEE SAID THAT THE SAFETY DEVICE WENT TO THE SIDE AND SHE POKED HERSELF".

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THERE WAS NEEDLE STICK INJURY - POST USE AND SAFETY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED A NEEDLE STICK OCCURRED. "WE HAD ANOTHER NEEDLE STICK WITH BD VACUTAINER 21G 1-1/4¿ THIS MORNING. THE STICK OCCURRED WHEN THE PHLEBOTOMIST FINGER SLIPPED TO THE SIDE. NOT FORWARD. THE EMPLOYEE SAID THAT THE SAFETY DEVICE WENT TO THE SIDE AND SHE POKED HERSELF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1410957 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 UNKNOWN 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other