BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MULTI DOSE INHALER ADAPTER

    MDR report key: 6736001 · Received July 24, 2017

    Report

    Report Number
    8022032-2017-00001
    Event Type
    Injury
    Date Received
    July 24, 2017
    Report Date
    June 15, 2017
    Manufacturer
    SOUTHMEDIC, INC.
    Product Code
    CAF
    PMA / PMN Number
    K101953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ROUGH EDGES ON MDI ADAPTOR SCRATCHED A PATIENT'S NECK. A NURSE ALSO CUT HER FINGER ON THE SAME AREA OF THE PRODUCT WHILE APPLYING THE CANISTER. AFFECTED PATIENT IS A PREMATURE INFANT. REPORTER INDICATED THE ROUGH AREA WAS WHERE THE VENTILATOR CIRCUIT WAS POSITIONED AT THE PATIENT'S TRACHEA. HEALTHCARE FACILITY IS PEDIATRIC CONNECTION, (B)(6). EVENT SAMPLE IS NOT AVAILABLE TO BE RETURNED. INITIAL IMPORTER OF RECORD DID NOT REPORT THIS INCIDENT TO THE FDA. (B)(4) PART NUMBER: SMDIA-1000; LOT NUMBER: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516633 MULTI DOSE INHALER ADAPTER VENTILATOR ADAPTER FOR USE WITH MDI CAF SOUTHMEDIC, INC. SMDIA-1000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA Other