BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EPILOR¿ PLASTIC LOR SYRINGE

    MDR report key: 6777066 · Received August 9, 2017

    Report

    Report Number
    9610847-2017-00051
    Event Type
    Malfunction
    Date Received
    August 9, 2017
    Date of Event
    July 11, 2017
    Report Date
    August 30, 2017
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    CAZ
    PMA / PMN Number
    K925902
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. NO LOT # PROVIDED. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ONE SAMPLE OF THE 7ML EPILOR SYRINGE WAS RETURNED (PRODUCT #405198, LOT #UNKNOWN). THE SAMPLE WAS LOOSE INSIDE A BOX. IT WAS VISUALLY INSPECTED AND WAS FOUND THAT THE STOPPER AND THE PLUNGER WERE SEPARATE; THE PLUNGER MOVED FREELY INSIDE THE BARREL AT THE MOMENT OF TAKING IT OUT OF THE BOX. THE PIECE WAS ASSEMBLED AND THEN IT WAS ACTIONED SEVERAL TIMES TO VERIFY THAT THEY DID NOT SEPARATE FROM EACH OTHER. NO PROBLEMS WERE FOUND. AFTER THE RESISTANCE TEST, AN AIR/WATER LEAK TEST WAS DONE AND WE COULD NOT CONFIRM OR DUPLICATE THE ISSUE. THE SEPARATING OF THE STOPPER COULD BE DONE DUE TO AN INCORRECT USE OF THE PRODUCT, IF THE TIP IS CLOSED OR PLUGGED AND THE PLUNGER WAS PULLED DOWN. A DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    WHILE USING THE EPIDURAL KIT FOR ANESTHESIA, THE BD EPILOR¿ PLASTIC LOR SYRINGE SEPARATED. NO REPORT OF SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563604 BD EPILOR¿ PLASTIC LOR SYRINGE ANESTHESIA SYRINGE CAZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other