BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC CONCENTRIC NEEDLES

    MDR report key: 14183870 · Received April 22, 2022

    Report

    Report Number
    3005581270-2022-00003
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 14, 2022
    Report Date
    July 15, 2022
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    UDI-DI
    05704736002882
    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). ON SEVERAL DIFFERENT PATIENTS, DURING VOLUNTARY CONTRACTION (MAINLY ILIOPSOAS, QUADRICEPS AND MEDIAL GASTROCNEMIUS MUSCLES), THE NEEDLES USED WERE TWISTED). NO INJURIES REPORTED. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 #10153070. PICTURES WERE PROVIDED FROM THE CUSTOMER OF THE AFFECTED PARTS. AFFECTED PARTS TO BE RETURNED FROM THE CUSTOMER. 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 (B)(6) 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 (B)(4) CORPORATE TRENDING AND ANALYSIS PROCEDURE) COMPLAINT TRENDS ARE ASSESSED AS PART OF THESE REVIEWS. A REVIEW OF COMPLAINT TRENDING IS COMPLETED QUARTERLY. LAST REVIEW (B)(6)REND FOR THIS FAILURE IDENTIFIED. DEVICE HISTORY RECORD - WO#322377 WAS REVIEWED. NO ISSUES NOTED DURING PRODUCTION. INSTALL DATE OF DEVICE RELEASE DATE: (B)(6) - 20/10/2021 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

    ON SEVERAL DIFFERENT PATIENTS, DURING VOLUNTARY CONTRACTION (MAINLY ILIOPSOAS, QUADRICEPS AND MEDIAL GASTROCNEMIUS MUSCLES), THE NEEDLES USED WERE TWISTED. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    ON SEVERAL DIFFERENT PATIENTS, DURING VOLUNTARY CONTRACTION (MAINLY ILIOPSOAS, QUADRICEPS AND MEDIAL GASTROCNEMIUS MUSCLES), THE NEEDLES USED WERE TWISTED. NO INJURIES REPORTED.

    Description of Event or Problem · 0

    ON SEVERAL DIFFERENT PATIENTS, DURING VOLUNTARY CONTRACTION (MAINLY ILIOPSOAS, QUADRICEPS AND MEDIAL GASTROCNEMIUS MUSCLES), THE NEEDLES USED WERE TWISTED. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2326377 DANTEC CONCENTRIC NEEDLES DANTEC CONCENTRIC NEEDLES IKT NATUS MANUFACTURING LIMITED 9013S0042 05704736002882

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown