BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN* LUMBAR CATHETER KIT

    MDR report key: 11736095 · Received April 28, 2021

    Report

    Report Number
    2023988-2021-00007
    Event Type
    Injury
    Date Received
    April 28, 2021
    Date of Event
    April 9, 2021
    Report Date
    April 9, 2021
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    JXG
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 (REF NATUS COMPLAINT#(B)(4)). INVESTIGATION RESULTS: COMPLAINT DESCRIBES AN EVENT WHERE A PIECE OF THE CATHETER WAS LEFT INSIDE THE PATIENT DUE TO USER ERROR. CUSTOMER CONFIRMED THEY CAUSED THE MALFUNCTION AND WANTED TO KNOW IF THE PRODUCT COULD BE LEFT INSIDE THE PATIENT OR IF ADDITIONAL INTERVENTION NEEDED TO BE DONE TO REMOVE THE EXTRA PIECE. CLINICAL RECOMMENDED TO REMOVE THE FOREIGN OBJECT. CUSTOMER CONFIRMED THE PRODUCT IS NOT RELATED TO PRODUCT PERFORMANCE. COMPLAINT FORM RETURNED, CONFIRMED AT THE TIME OF THE FAILURE, THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY. THE AFFECTED PRODUCT WILL NOT BE RETURNED. REVIEW OF PRODUCT EVALUATION FORM SHOWS NO ASSOCIATED CAPAS. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 0 CONFIRMED COMPLAINTS, GIVING AN INCIDENT RATE OF (B)(4). REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS AN ACCEPTABLE RISK. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 4.39 (B)(4) CAMINO ICP MONITOR RISK ANALYSIS. UNABLE TO PERFORM DEVICE HISTORY RECORD REVIEW AS THE CUSTOMER DID NOT REPORT THE DEVICE LOT NUMBER. MANUFACTURING DATE IS UNABLE TO BE DETERMINED AS CUSTOMER DID NOT PROVIDE THE LOT NUMBER. INVESTIGATION RESULT CODE: SAN DIEGO/EDS PRODUCTS/NO RETURN OF DEVICE FOR EVALUATION CLOSURE RATIONALE:LOW SAFETY RISK OF HARM, INDIVIDUAL COMPLAINT RELATED TO ISSUE STATED. COMPLAINT WILL BE INCLUDED IN TRENDING DATA FOR FURTHER REVIEW AND INVESTIGATION IF NEEDED.

    Description of Event or Problem · 0

    LUMBAR CATHETER (821707) DISTAL TIP SHEARED OFF IN A PATIENT DUE TO USER ERROR. COMPLAINT IS NOT RELATED TO PRODUCT PERFORMANCE. THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY.

    Additional Manufacturer Narrative · 1

    INITIAL REPORT (REF NATUS COMPLAINT#(B)(4)). INVESTIGATION RESULTS: COMPLAINT DESCRIBES AN EVENT WHERE A PIECE OF THE CATHETER WAS LEFT INSIDE THE PATIENT DUE TO USER ERROR. CUSTOMER CONFIRMED THEY CAUSED THE MALFUNCTION AND WANTED TO KNOW IF THE PRODUCT COULD BE LEFT INSIDE THE PATIENT OR IF ADDITIONAL INTERVENTION NEEDED TO BE DONE TO REMOVE THE EXTRA PIECE. CLINICAL RECOMMENDED TO REMOVE THE FOREIGN OBJECT. CUSTOMER CONFIRMED THE PRODUCT IS NOT RELATED TO PRODUCT PERFORMANCE. COMPLAINT FORM RETURNED, CONFIRMED AT THE TIME OF THE FAILURE, THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY. THE AFFECTED PRODUCT WILL NOT BE RETURNED. REVIEW OF PRODUCT EVALUATION FORM SHOWS NO ASSOCIATED CAPAS. COMPLAINT HISTORY WAS REVIEWED FOR THE PREVIOUS TWO YEARS AND FOUND 0 CONFIRMED COMPLAINTS, GIVING AN INCIDENT RATE OF (B)(4). REVIEW OF MEDICAL DEVICE HAZARD ANALYSIS SHOWS INCIDENT TO IDENTIFY AS AN ACCEPTABLE RISK. ACCEPTABLE RISK ASSOCIATED WITH THE COMPLAINT AS PER LINE 4.39 (B)(4) CAMINO ICP MONITOR RISK ANALYSIS. INVESTIGATION RESULT CODE: (B)(4) /EDS PRODUCTS/NO RETURN OF DEVICE FOR EVALUATION.

    Description of Event or Problem · 1

    LUMBAR CATHETER (821707) DISTAL TIP SHEARED OFF IN A PATIENT DUE TO USER ERROR. COMPLAINT IS NOT RELATED TO PRODUCT PERFORMANCE. THERE WAS NO PATIENT INJURY OR DELAY IN SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632257 CODMAN* LUMBAR CATHETER KIT CODMAN* LUMBAR CATHETER KIT JXG NATUS MEDICAL INCORPORATED 821707

    Patients

    Seq Age Sex Outcome Treatment
    1