BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERIFIX®

    MDR report key: 7842509 · Received September 4, 2018

    Report

    Report Number
    2523676-2018-00070
    Event Type
    Injury
    Date Received
    September 4, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 27, 2018
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    OGE
    UDI-DI
    04046964178948
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLES WERE RETURNED FOR EVALUATION IN CONNECTION WITH THIS INCIDENT. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO OBTAIN A SAMPLE. WITHOUT THE ACTUAL DEVICE, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE PERFORMED FOR THE REPORTED LOT NUMBER REVEALED NO ABNORMALITIES OR NON-CONFORMANCES NOTED DURING IN PROCESS OR FINAL PRODUCT INSPECTION. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF A SAMPLE AND/OR ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS NOT YET BEEN RECEIVED AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE RESULTS OF THE INVESTIGATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: DURING THE INITIAL PLACEMENT OF THE CATHETER FOR A PATIENT IN LABOR, THE TIP OF THE CATHETER BROKE OFF INSIDE THE PATIENT. THE FACILITY STATED THE CATHETER DID NOT THREAD EASILY, HOWEVER IT FLUSHED EASILY. WHEN THE CATHETER WAS RETRACTED, THE CLINICIAN NOTICED APPROXIMATELY 34 MM OF THE CATHETER TIP TO BE MISSING. THE CLINICIAN FLUSHED THE NEEDLE AND NO REMNANTS WERE FOUND. THE ENVIRONMENT AREA WAS ALSO CHECKED AND NO REMNANTS WERE FOUND. PATIENT HAD A NEUROSURGICAL CONSULT AND UNDERWENT A CT SCAN AND A SPINAL X-RAY. NO REMNANTS WERE FOUND ON THE SCANS OR THE X-RAY. NO FURTHER INTERVENTIONS WERE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683073 PERIFIX® EPIDURAL ANESTHESIA KIT OGE B. BRAUN MEDICAL INC. 0061619575 04046964178948

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other