BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX®

    MDR report key: 20309641 · Received September 26, 2024

    Report

    Report Number
    9610825-2024-00729
    Event Type
    Malfunction
    Date Received
    September 26, 2024
    Date of Event
    June 11, 2022
    Report Date
    September 26, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    OGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. AFTER CHECKING THE RESPECTIVE DOCUMENTATION OF THE PRODUCTION, NO DEVIATIONS COULD BE IDENTIFIED IN THE MENTIONED TIME PERIOD. 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. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "DURING LUMBAR EPIDURAL PLACEMENT FOR VAGINAL DELIVERY, WE WERE ABLE TO INSERT THE CATHETER INTO THE EPIDURAL SPACE AND REMOVE THE TUOHY NEEDLE. WHEN WE TRIED TO WITHDRAW THE CATHETER SEVERAL CENTIMETERS TO ADAPT THE DISTANCE OF THE CATHETER BETWEEN THE SKIN AND THE SPACE, WE ENCOUNTERED RESISTANCE AND THEN RUPTURE OF THE CATHETER, ABOUT 6CM SUBCUTANEOUSLY. FORTUNATELY, THERE WAS NO NEUROLOGICAL DEFICIT IN THE PATIENT. FRAGMENT OF THE EPIDURAL CATHETER REMAINED SUBCUTANEOUS. CT SCAN FOR PRECISE LOCATION OF THE CATHETER AND SEARCH FOR A MECHANICAL CAUSE OF THE DIFFICULTIES IN REMOVAL AND SECTIONING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2263426 PERIFIX® EPIDURAL ANESTHESIA OGE B BRAUN MELSUNGEN AG 4514017C 22B28A8701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female