BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOCK¿ SYRINGE

    MDR report key: 15709760 · Received November 1, 2022

    Report

    Report Number
    8041187-2022-00636
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 10, 2022
    Report Date
    November 4, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    00382903057887
    PMA / PMN Number
    K161170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED LOT# 1201099 WAS NOT FOUND FOR THE REPORTED CATALOG# 305788. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE#: 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

    H6: INVESTIGATION SUMMARY : OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON REVIEW OF THE SUPPLIED PHOTOS AND COMPLAINT RECORDS. ANALYSIS OF PREVIOUS RECORDS SHOWED THAT EXCESSIVE LUBRICANT WAS PRESENT ON THE PLUNGER OF THE SYRINGE. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS RELATED TO THE MANUFACTURING PROCESS. SILICONE IS USED AS A LUBRICANT DURING MANUFACTURING AND EXCESS SILICONE CAN BE APPLIED TO THE PRODUCT, RESULTING IN WHAT APPEARS TO BE AN OILY SUBSTANCE. CORRECTIVE ACTIONS HAVE BEEN MADE TO ADDRESS THIS ISSUE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH WAS IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN, OIL-LIKE RESIDUE WAS FOUND ON THE PLUNGER OF THE BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOCK¿ SYRINGE WHILE DRAWING UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS MORNING, A NURSE BROUGHT SOMETHING TO MY ATTENTION ABOUT THESE SPECIFIC BD SYRINGES. THEIR PRIMARY PURPOSE IS FOR SUBCUTANEOUS HEPARIN INJECTION. WHEN THE NURSE BEGAN TO DRAW THE MEDICATION UP INTO THE SYRINGE, SHE NOTICED AN OIL LIKE RESIDUE ON THE PLUNGER OF THE SYRINGE WHEN IT WAS PULLED BACK. WE DON¿T BELIEVE WE¿VE SEEN ANYTHING LIKE THIS ON ANY OF THE OTHER SYRINGES WE USE ON THE UNIT, SO WE WANTED TO BRING THIS FORWARD TO YOU IN CASE THIS IS SOME SORT OF DEFECT."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN, OIL-LIKE RESIDUE WAS FOUND ON THE PLUNGER OF THE BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOCK¿ SYRINGE WHILE DRAWING UP MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THIS MORNING, A NURSE BROUGHT SOMETHING TO MY ATTENTION ABOUT THESE SPECIFIC BD SYRINGES. THEIR PRIMARY PURPOSE IS FOR SUBCUTANEOUS HEPARIN INJECTION. WHEN THE NURSE BEGAN TO DRAW THE MEDICATION UP INTO THE SYRINGE, SHE NOTICED AN OIL LIKE RESIDUE ON THE PLUNGER OF THE SYRINGE WHEN IT WAS PULLED BACK. WE DON¿T BELIEVE WE¿VE SEEN ANYTHING LIKE THIS ON ANY OF THE OTHER SYRINGES WE USE ON THE UNIT, SO WE WANTED TO BRING THIS FORWARD TO YOU IN CASE THIS IS SOME SORT OF DEFECT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461730 BD ECLIPSE¿ INJECTION NEEDLE WITH LUER-LOCK¿ SYRINGE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) SEE H10 00382903057887

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown