BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2

    MDR report key: 7934594 · Received October 4, 2018

    Report

    Report Number
    9610048-2018-00145
    Event Type
    Injury
    Date Received
    October 4, 2018
    Date of Event
    September 12, 2018
    Report Date
    October 12, 2018
    Manufacturer
    BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
    Product Code
    BSP
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE BD JUNCOS 405155, LOTS 7013875 AND 7044833 USED ON (B)(4), LOT 8038713. THE SUB-ASSEMBLY MATERIAL NUMBER: (B)(4), SPINAL NEEDLE 27 X 3 1/2IN QUINCKE- BULK. NO PICTURES OR SAMPLES INCLUDED IN THE COMPLAINT RECORD. BD JUNCOS WAS NOT ABLE TO CONFIRM THAT THE CUSTOMER¿S INDICATED FAILURE MODE IS ASSOCIATED WITH THE MANUFACTURING PROCESSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2 BROKE DURING WITHDRAWAL, THE PATIENT ¿HAD A FRONTAL DISPLACEMENT AND THE NEEDLE BROKE¿. A PIECE OF THE NEEDLE REMAINED IN THE PATIENT. FURTHERMORE, THE PATIENT RECEIVED SURGERY IN ORDER TO REMOVE THE NEEDLE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2 BROKE DURING WITHDRAWAL, THE PATIENT ¿HAD A FRONTAL DISPLACEMENT AND THE NEEDLE BROKE¿. A PIECE OF THE NEEDLE REMAINED IN THE PATIENT. FURTHERMORE, THE PATIENT RECEIVED SURGERY IN ORDER TO REMOVE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777424 BD¿ NEEDLE FOR SPINAL ANESTHESIA SPINAL 27GX3 - 1/2 SPINAL NEEDLE BSP BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 8038713

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention