BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ SAFETY NEEDLE

    MDR report key: 16585576 · Received March 21, 2023

    Report

    Report Number
    3002682307-2023-00074
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    March 1, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903058914
    PMA / PMN Number
    K100209
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 12-APR-2023. H6: INVESTIGATION SUMMARY A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305891 AND BATCH NUMBER 2211001. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, AN ENTIRE BOX OF ECLIPSE NEEDLES WAS RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. TWENTY (20) RANDOM NEEDLES WERE SELECTED FOR THOROUGH EXAMINATION. THE NEEDLES WERE ASSEMBLED WITH A BD DISCARDIT 2ML SYRINGE; HOWEVER, NO SIGNS OF DEFECTIVE CONNECTION OR LEAKAGE WERE OBSERVED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE RELATED TO THE MANUFACTURING PROCESS COULD NOT BE DETERMINED FOR THIS INCIDENT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VACCINE MEDICATION LEAKED OUT OF THE BD ECLIPSE¿ SAFETY NEEDLE DURING USE DUE TO A BAD CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE ARE THE ORANGE NEEDLES WITH ITEM NUMBER 305891 AND LOT NUMBER 2211001. THESE HAVE A BAD CONNECTION, RESULTING IN VACCINE REGULARLY RUNNING DOWN THE NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT VACCINE MEDICATION LEAKED OUT OF THE BD ECLIPSE¿ SAFETY NEEDLE DURING USE DUE TO A BAD CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THESE ARE THE ORANGE NEEDLES WITH ITEM NUMBER 305891 AND LOT NUMBER 2211001. THESE HAVE A BAD CONNECTION, RESULTING IN VACCINE REGULARLY RUNNING DOWN THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366293 BD ECLIPSE¿ SAFETY NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 2211001 00382903058914

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown