BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC CONCENTRIC NEEDLES

    MDR report key: 14183988 · Received April 22, 2022

    Report

    Report Number
    3005581270-2022-00002
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 22, 2022
    Report Date
    July 13, 2022
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K112034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT# (B)(4). THE NEEDLE BENDS, TWISTS AND DOES NOT PENETRATE THE PATIENT'S MUSCLE. THIS CAUSES PAIN. THE NEEDLE DOES NOT BREAK. NO INJURIES REPORTED. THE INCIDENT REOCCURRED ON SEVERAL PATIENTS. THE PRACTITIONER IS EXPERIENCED AND ACCUSTOMED TO PERFORMING THIS EXAMINATION. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 #(B)(4). PICTURES WERE PROVIDED FROM THE CUSTOMER OF THE AFFECTED PARTS. AFFECTED PARTS WERE RETURNED TO SALES. PARTS TO BE EVALUATED AND INVESTIGATION RESULTS TO BE DOCUMENTED ONCE THEY BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REFERENCE NATUS COMPLAINT (B)(4). RETURNS WERE RECEIVED FROM THE CUSTOMER AND VISUAL INSPECTION WAS CARRIED OUT BY ENGINEERING. NO ISSUES NOTED DURING INSPECTION. IT WAS CONFIRMED THAT NEEDLES DID NOT HAVE BLUNT TIPS. THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THE CURRENT RISK FILE DOC-010776 REV L HAZARD ID 6.5 IDENTIFIES THIS ISSUE HARM - PATIENT DISCOMFORT DURING PROCEDURE MAY INCREASE.. CAUSE- NEEDLE IS PERCEIVED AS BEING MORE DIFFICULT TO INSERT THAN EXPECTED / INCREASED FORCE REQUIRED TO INSERT THE NEEDLE DUE TO HIGH FRICTION. SEVERITY- MARGINAL (3). RISK LEVEL- MINOR (3). A RISK REVIEW IS NOT REQUIRED AS THIS COMPLAINT DOES NOT DESCRIBE A NEW FAILURE MODE OR NEW HARM AND THE EXISTING HAZARD SEVERITY AND/OR PROBABILITY OF OCCURRENCE HAS NOT CHANGED. COMPLAINTS ARE REVIEWED ROUTINELY PER QUALITY SYSTEM REQUIREMENTS (QMS-004442 CORPORATE TRENDING AND ANALYSIS PROCEDURE)COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW DOC-059297. NO TREND FOR THIS FAILURE IDENTIFIED. DEVICE HISTORY RECORD - WO#257173 WAS REVIEWED. NCR025372 WAS NOTED DUE TO TEMPERATURE CHECK FOR THE CLEANROOM FAILING ON THE 04 MAY 2021. THIS NCR IS NOW CLOSED. THERE WAS NO ADVERSE EFFECTS TO PRODUCT PERFORMANCE, SAFETY, OR EFFICACY. RELEASE DATE: (B)(6) - 17 JUN 2021. A SEARCH FOR SERVICE DATA THAT MAY BE RELEVANT TO THIS ISSUE HAS BEEN CONDUCTED. NO FURTHER INFORMATION RELATED TO THIS ISSUE FOUND. CLOSURE RATIONALE: COMPLAINT COULD NOT BE VERIFIED, MONITOR FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    THE NEEDLE BENDS, TWISTS AND DOES NOT PENETRATE THE PATIENT'S MUSCLE. THIS CAUSES PAIN. THE NEEDLE DOES NOT BREAK. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    THE NEEDLE BENDS, TWISTS AND DOES NOT PENETRATE THE PATIENT'S MUSCLE. THIS CAUSES PAIN. THE NEEDLE DOES NOT BREAK. NO INJURIES REPORTED

    Description of Event or Problem · 0

    THE NEEDLE BENDS, TWISTS AND DOES NOT PENETRATE THE PATIENT'S MUSCLE. THIS CAUSES PAIN. THE NEEDLE DOES NOT BREAK. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957078 DANTEC CONCENTRIC NEEDLES DANTEC CONCENTRIC NEEDLES IKT NATUS MANUFACTURING LIMITED 9013S0012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown