BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENCAN®

    MDR report key: 16531623 · Received March 13, 2023

    Report

    Report Number
    2523676-2023-00062
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    February 27, 2023
    Report Date
    April 27, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    OFU
    UDI-DI
    04046964180606
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. A THOROUGH INVESTIGATION COULD NOT BE PERFORMED WITHOUT A SAMPLE TO EVALUATE. THEREFORE, NO ROOT CAUSE IS ABLE TO BE DETERMINED AT THIS TIME. ALTHOUGH THE TIP OF THE NEEDLE WAS REPORTED TO BE BROKEN OFF, SINCE IT WAS NOT BROKEN OR DAMAGED UPON THE OPENING OF THE KIT AND IT HAD BEEN USED IN A PROCEDURE, PER THE MANUFACTURERS INVESTIGATION THIS DEFECT IS NOT LIKELY TO HAVE HAPPENED DURING THE MANUFACTURING PROCESS. IT IS BELIEVED TO HAPPEN DURING APPLICATION. THE USER WILL BE REFERRED TO THE IFU WHICH STATES, " DO NOT APPLY EXCESSIVE FORCE DURING NEEDLE ADVANCEMENT. DO NOT UTILIZE NEEDLE IF IT BENDS OR TIP BECOMES DAMAGED. IF RESISTANCE IS FELTDURING ADVANCEMENT OF THE NEEDLE, CAREFULLY CORRECT THE ORIENTATION OF THE NEEDLE BUT NEVER APPLY EXCESSIVE FORCE." A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS(B)(6) MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: SPINAL NEEDLE BROKE IN PATIENT'S BACK. AS REPORTED BY THE CUSTOMER, "NO INJURY; MEDICAL INTERVENTION NECESSARY; TYPE OF INTERVENTION: NEEDLE REMOVAL, DO NOT HAVE DETAILS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1714204 PENCAN® SPINAL ANESTHESIA KIT OFU B. BRAUN MEDICAL INC. 333851 0061866717 04046964180606

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention