BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC DCN DISP NEEDLE ELECTRODE, 1"(25MM)X0.30MM

    MDR report key: 19773050 · Received July 18, 2024

    Report

    Report Number
    3005581270-2024-00002
    Event Type
    Malfunction
    Date Received
    July 18, 2024
    Date of Event
    June 14, 2024
    Report Date
    November 8, 2024
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K143433
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    REF NATUS COMPLAINT# (B)(4). THE CUSTOMER NOTED THE FOLLOWING: CLINICAL CONSEQUENCES OBSERVED: ADDITIONAL COSTS ASSOCIATED WITH MORE FREQUENT CABLE CHANGES. EXAMINATIONS THAT ARE DIFFICULT TO PERFORM FOR DOCTORS AND PAINFUL FOR PATIENTS. PRECAUTIONARY MEASURES AND ACTIONS TAKEN: CHANGING THE NEEDLE TO DO THE EMG TEST. THE AFFECTED EMG NEEDLES WERE NOT PRESERVED. A QUESTIONNAIRE HAS BEING SENT TO THE CUSTOMER AND RETURNS ARE REQUESTED FOR INVESTIGATION. RISK REVIEW: PER DOC-(B)(4) REV O RISK ANALYSIS SPREADSHEET- DANTEC DCN HAZARD ID 6.3 CAUSE - NEEDLES SHOULD BE SHARP. NEEDLE MAY BECOME BLUNTED / HOOKED/ NEEDLES LOSING THEIR SHARPNESS EFFECT (HARM)- PATIENT DISCOMFORT DURING PROCEDURE MAY INCREASE. RESIDUAL RISK - MODERATE. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP 001 REF NATUS COMPLAINT#(B)(4). A COMPLETED QUESTIONNAIRE WAS RETURNED BY THE CUSTOMER. IT WAS CONFIRMED 3 NEEDLES FROM THE SAME LOT NUMBER ARE AVAILABLE FOR EVALUATION. AWAITING RETURN OF THESE NEEDLES TO THE (B)(6) FACILITY.

    Additional Manufacturer Narrative · 0

    FOLLOW UP 002 REF NATUS COMPLAINT#(B)(4). UPDATE TO SECTION D4 EXPIRATION DATE. UPDATE TO SECTION H4 MANUFACTURER DATE. REVIEW OF DEVICE HISTORY RECORD: WORK ORDER (B)(4). DOES NOT SHOW ANY ANOMALIES FOR THE COMPLAINT. NO UNUSUAL SCRAP NOTED ON ANY OPERATION STEP AND BATCH HAD A 98.52% YIELD. PRODUCT EXAMINATION: UPON REVIEW OF THE RETURNED PRODUCT, THE PRODUCT WAS COMPARED AGAINST VISUAL AID DOC- (B)(4). - NO FAILURES NOTED FOR BLUNT TIPS. FROM THIS INVESTIGATION, THE DEVICE HISTORY RECORD REVIEW DID NOT SHOW ANY ANOMALIES FOR THE COMPLAINT INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS, THE DEFECT WAS NOT PRESENT ON THE RETURNED PRODUCT AND NO COMPLAINTS FOR THIS ISSUE HAVE BEEN RECEIVED IN THE 12-MONTH PERIOD. NO CORRECTIVE OR PREVENTIVE ACTION REQUIRED.

    Description of Event or Problem · 0

    PART 9013S0012 DANTEC DCN DISP NEEDLE ELECTRODE - DOCTORS HAVE FOUND THAT THE EMG NEEDLES ARE NOT SHARP ENOUGH AND ARE TOO ROUGH. THIS LEADS TO EMG EXAMINATIONS THAT ARE MORE DIFFICULT TO PERFORM AND THEREFORE MORE PAIN FOR PATIENTS. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART 9013S0012 DANTEC DCN DISP NEEDLE ELECTRODE - DOCTORS HAVE FOUND THAT THE EMG NEEDLES ARE NOT SHARP ENOUGH AND ARE TOO ROUGH. THIS LEADS TO EMG EXAMINATIONS THAT ARE MORE DIFFICULT TO PERFORM AND THEREFORE MORE PAIN FOR PATIENTS.. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    PART 9013S0012 DANTEC DCN DISP NEEDLE ELECTRODE - DOCTORS HAVE FOUND THAT THE EMG NEEDLES ARE NOT SHARP ENOUGH AND ARE TOO ROUGH. THIS LEADS TO EMG EXAMINATIONS THAT ARE MORE DIFFICULT TO PERFORM AND THEREFORE MORE PAIN FOR PATIENTS.. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1500250 DANTEC DCN DISP NEEDLE ELECTRODE, 1"(25MM)X0.30MM DANTEC DCN DISP NEEDLE ELECTRODE, 1"(25MM)X0.30MM IKT NATUS MANUFACTURING LIMITED 9013S0012 21A/23/D

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown