BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DANTEC CONCENTRIC NEEDLES

    MDR report key: 18155882 · Received November 16, 2023

    Report

    Report Number
    3005581270-2023-00006
    Event Type
    Malfunction
    Date Received
    November 16, 2023
    Report Date
    January 26, 2024
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K112034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORT REFERENCE TO COMPLAINT (B)(4). TECHNICAL SERVICE HAS REQUESTED THE PART NUMBER, LOT NUMBER AND ASKED THE DP TO CONFIRM IF ANY PATIENTS WERE INJURED. 23 OCT 2023 - LOT # AND PART # NOT YET RECEIVED. QUESTIONNAIRE SENT FOR FURTHER INFORMATION. 03 NOV 2023 - TECHNICAL SERVICE FOLLOWED UP WITH CUSTOMER FOR QUESTIONNAIRE, PART AND MORE INFORMATION. NO RESPONSE AS OF 06 NOV 2023. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001, REFERENCE TO NATUS COMPLAINT#(B)(4). SEVERAL ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER, REQUESTING THEM TO RETURN QUESTIONNAIRE AND PROVIDE THE PART, LOT NUMBER OF THE AFFECTED PRODUCT. 22 DEC 2023: THE QUESTIONNAIRE WAS RECEIVED, NO LOT # OR PART NUMBER PROVIDED BY THE CUSTOMER DESPITE SEVERAL REQUESTS. IT WAS CONFIRMED THERE WAS NO INJURY AND NO MEDICAL INTERVENTION NEEDED DURING OR AFTER THE USE OF THE PRODUCT. IT WAS ALSO CONFIRMED THAT THE AFFECTED PRODUCT WILL NOT BE RETURNED TO NATUS FOR EVALUATION. UDI NUMBER / MANUFACTURING DATE IS NOT DOCUMENTED AS THE CUSTOMER HAS NOT CONFIRMED THE PART NUMBER. NO RELATED CAPAS. PRODUCT EXAMINATION IS NOT POSSIBLE AS THE CUSTOMER DID NOT PROVIDE MORE INFORMATION ON THE ISSUE WHEN REQUESTED AND DID NOT RETURN THE PARTS. FINAL REVIEW AND APPROVAL OF INVESTIGATION DETAILS TO BE COMPLETED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002, REFERENCE TO NATUS COMPLAINT# (B)(4). PER (B)(4) REV N RISK ANALYSIS SPREADSHEET- DANTEC DCN. HAZARD ID 6.5 - NEEDLE IS PERCEIVED AS BEING MORE DIFFICULT TO INSERT THAN EXPECTED / INCREASED FORCE REQUIRED TO INSERT THE NEEDLE DUE TO HIGH FRICTION. EFFECTS (HARM): PATIENT DISCOMFORT DURING PROCEDURE MAY INCREASE. RBA RATING LOW. FINAL REVIEW AND APPROVAL OF INVESTIGATION DETAILS WAS COMPLETED. FAILURE WAS NOT CONFIRMED. PRODUCT EXAMINATION WAS NOT POSSIBLE AS THE CUSTOMER DID NOT PROVIDE MORE INFORMATION ON THE ISSUE WHEN REQUESTED AND DID NOT RETURN THE PARTS. COMPLAINT FILE CLOSED (B)(6) 2024.

    Description of Event or Problem · 0

    DANTEC CONCENTRIC NEEDLES - IT WAS REPORTED THAT NEEDLES GET BENT WHEN INSIDE THE MUSCLE.

    Description of Event or Problem · 0

    DANTEC CONCENTRIC NEEDLES - IT WAS REPORTED THAT NEEDLES GET BENT WHEN INSIDE THE MUSCLE.

    Description of Event or Problem · 0

    DANTEC CONCENTRIC NEEDLES - IT WAS REPORTED THAT NEEDLES GET BENT WHEN INSIDE THE MUSCLE. NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912075 DANTEC CONCENTRIC NEEDLES DANTEC CONCENTRIC NEEDLES IKT NATUS MANUFACTURING LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown