BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 8582334 · Received May 6, 2019

    Report

    Report Number
    8041187-2019-00348
    Event Type
    Malfunction
    Date Received
    May 6, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 30, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057802
    PMA / PMN Number
    SEE H.10.
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: PHOTO EVALUATION: 2 PHOTOS WERE RECEIVED FOR INVESTIGATION AND OBSERVE THE SYRINGE BARREL IS DAMAGED/DISTORTED. SAMPLE EVALUATION: 1 ACTUAL SAMPLE IN OPEN PACKAGE WAS RECEIVED FOR INVESTIGATION. THE SAMPLE WAS NOT DECONTAMINATED. THE ACTUAL SAMPLE IS SUBJECTED TO VISUAL INSPECTION. OBSERVED DAMAGED BARREL ON THE 1ML SYRINGE PRODUCT . THE COMPLAINT IS CONFIRMED AND PRODUCT IS OUT OF SPECIFICATION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE SCRATCH GOES THROUGH THE "SINGLE USE ONLY" WITHOUT REMOVING ANY INK WHICH INDICATED THIS HAPPENED PRIOR TO THE PARKING OF THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE BARREL WAS FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN BARREL".

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: FMF. MEDICAL DEVICE TYPE: PISTON SYRINGE. THERE WERE MULTIPLE PMA / 510(K)#S REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: PMA / 510(K)#: K941562, PMA / 510(K)#: K161170. 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 · 1

    IT WAS REPORTED THAT THE BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE BARREL WAS FOUND BROKEN BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BROKEN BARREL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378226 BD ECLIPSE¿ BD LUER-LOK¿ SYRINGE WITH DETACHABLE NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 8207169 30382903057802

    Patients

    Seq Age Sex Outcome Treatment
    1 Other