BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX PENCIL POINT SPINAL NEEDLE SETS (WHITACRE)

    MDR report key: 13579211 · Received February 22, 2022

    Report

    Report Number
    3012307300-2022-03820
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    January 21, 2022
    Report Date
    February 22, 2022
    Manufacturer
    NULL
    Product Code
    MIA
    PMA / PMN Number
    K172410
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. FURTHER INVESTIGATION WILL BE CONDUCTED BY THE SUPPLIER, TAE-CHANG INDUSTRIAL CO. LTD.

    Additional Manufacturer Narrative · 0

    ONE UNIT WAS RETURNED FOR INVESTIGATION. UPON PHYSICAL INSPECTION, IT WAS FOUND THAT THE COMPLAINED ISSUE COULD BE DUPLICATED. FURTHER INVESTIGATION WILL BE CONDUCTED BY THE SUPPLIER, (B)(4) CO. LTD.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN INSERTING THE NEEDLE FOR A SPINAL ANESTHESIA, THE NEEDLE BROKE IN TWO PIECES AND ONE STAYED IN PATIENT'S SPINE. BROKEN NEEDLE PIECE WAS REMOVED AND CHECKED USING AN IMAGE INTENSIFIER. NO FURTHER CLINICAL CONSEQUENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN INSERTING THE NEEDLE FOR A SPINAL ANESTHESIA, THE NEEDLE BROKE IN TWO PIECES AND ONE STAYED IN PATIENT'S SPINE. BROKEN NEEDLE PIECE WAS REMOVED AND CHECKED USING AN IMAGE INTENSIFIER. NO FURTHER CLINICAL CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1004812 PORTEX PENCIL POINT SPINAL NEEDLE SETS (WHITACRE) NEEDLE, SPINAL, SHORT TERM MIA 4178355

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown