BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HVE (HIGH VOLUME EVACUATOR) TIPS

    MDR report key: 18247340 · Received December 1, 2023

    Report

    Report Number
    1319130-2023-00014
    Event Type
    Malfunction
    Date Received
    December 1, 2023
    Date of Event
    November 2, 2023
    Report Date
    December 1, 2023
    Manufacturer
    SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL.
    Product Code
    EHZ
    UDI-DI
    10732224000579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CROSSTEX HAS MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE REPORTED EVENT. TO DATE, WE HAVE NOT RECEIVED A RESPONSE. AS NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THE REPORTED EVENT, A ROOT CAUSE COULD NOT BE DETERMINED. CROSSTEX WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THAT THEIR SLOTTED EVACUATOR TIPS ARE ABRASIVE AND CUTTING PATIENT'S LIPS. IT IS UNKNOWN IF THE PATIENT'S RECEIVED MEDICAL TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1606079 HVE (HIGH VOLUME EVACUATOR) TIPS SLOTTED EVACUATOR TIPS EHZ SPSMEDICAL SUPPLY CORP. A DIV. OF CROSSTEX INTL. 22357410 22740091 & 20908322 10732224000579

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown