BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM SPINAL ANESTHESIA TRAY

    MDR report key: 4687692 · Received April 10, 2015

    Report

    Report Number
    2523676-2015-00118
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 13, 2015
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Product Code
    CAZ
    PMA / PMN Number
    K112515
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC INTERNAL REPORT # (B)(4). MULTIPLE FOLLOW UP ATTEMPTS MADE TO THE REPORTING FACILITY TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL. THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVAL. WITHOUT THE ACTUAL SAMPLE, A THOROUGH EVAL COULD NOT BE PERFORMED. WHILE NO SPECIFIC CONCLUSION CAN BE DRAWN, INCIDENTS OF THIS NATURE CAN GENERALLY OCCUR WHEN THE NEEDLE IS SUBJECTED TO SOME TYPE OF TRAUMA DURING USE THAT STRESSES THE DEVICE BEYOND ITS DESIGN CAPABILITIES. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DIDN OT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR NEEDLE MATERIAL NUMBER. THERE WERE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBER. ALL AVAILABLE INFO HAS BEEN FORWARDED TO THE DEVICE MANUFACTURER OF THE NEEDLE. IF ADD'L PERTINENT INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS WHEN PULLING THE NEEDLE OUT, A "POP" WAS HEARD, AND IT WAS NOTICED THAT THE NEEDLE WAS SEPARATED COMPLETELY FROM THE HUB. THE NEEDLE WAS ABLE TO BE REMOVED WITHOUT SURGICAL MEASURE. THERE WAS NO PT INJURY. THE NEEDLE WAS DISCARDED. IT IS UNK IF ANY DIFFICULTY WAS NOTED DURING INSERTION OR REMOVAL OF THE NEEDLE. IT IS ALSO UNK WHAT TYPE OF PROCEDURE WAS BEING PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238165 CUSTOM SPINAL ANESTHESIA TRAY PENCAN 25 GA. SPINAL NEEDLE CAZ B. BRAUN MEDICAL, INC. NA 0061379555

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK