BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EPILOR¿ PLASTIC LOR SYRINGE

    MDR report key: 14336353 · Received May 9, 2022

    Report

    Report Number
    9610847-2022-00174
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 15, 2022
    Report Date
    May 31, 2022
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    CAZ
    PMA / PMN Number
    K925902
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: OUR QUALITY ENGINEER INSPECTED THE 5 PHOTOS SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS NOT CONFIRMED UPON INSPECTION OF THE PHOTOS. BD CANNOT CONFIRM THE CAUSE OF THE FAILURE TO OUR MANUFACTURING PROCESS SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD EPILOR¿ PLASTIC LOR SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE HAD DROPS OF WHAT APPEARS TO BE SOME LIQUID INSIDE THE SYRINGE. DROPS OF WHAT APPEARS TO BE SOME LIQUID INSIDE THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD EPILOR¿ PLASTIC LOR SYRINGE FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE SYRINGE HAD DROPS OF WHAT APPEARS TO BE SOME LIQUID INSIDE THE SYRINGE. DROPS OF WHAT APPEARS TO BE SOME LIQUID INSIDE THE SYRINGE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2243237 BD EPILOR¿ PLASTIC LOR SYRINGE ANESTHESIA CONDUCTION KIT CAZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown