BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TECA CONCENTRIC NEEDLES

    MDR report key: 17547610 · Received August 15, 2023

    Report

    Report Number
    3005581270-2023-00001
    Event Type
    Malfunction
    Date Received
    August 15, 2023
    Date of Event
    August 3, 2023
    Report Date
    October 6, 2023
    Manufacturer
    NATUS MANUFACTURING LIMITED
    Product Code
    IKT
    PMA / PMN Number
    K112034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 001 REFERENCE COMPLAINT# (B)(4). THE CURRENT RISK FILE (B)(6). REV 13 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. RETURNS HAVE BEEN REQUESTED FOR INVESTIGATION/EXAMINATION. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Additional Manufacturer Narrative · 0

    FOLLOW UP REPORT 002 REFERENCE COMPLAINT# (B)(4). THERE ARE NO CAPA'S RELATED TO THIS ISSUE. THE DEVICE HISTORY RECORD FOR WORK ORDER (B)(4) HAS BEEN REVIEWED AND DOES NOT SHOW ANY ANOMALIES FOR THE COMPLAINT INCLUDING A REVIEW OF ALL APPLICABLE MEASUREMENTS. NEEDLES DEEMED DIFFICULT TO INSERT COULD BE CAUSED BY BLUNT TIPS. THIS IS 100% INSPECTED FOR AT THE ELECTROPOLISH STEP IN THE MANUFACTURE OF CONCENTRIC NEEDLES. THERE WERE A TOTAL OF (B)(4) NEEDLES SCRAPPED AT THE 100% INSPECTION STEP. THESE WERE FOR A MIX OF DAMAGED NEEDLES FROM THE GRINDING WHEEL OR UNEVEN FACETS. NO BLUNTS OBSERVED. PRODUCT EXAMINATION: UPON REVIEW OF THE RETURNED PRODUCT, THE PRODUCT WAS COMPARED AGAINST VISUAL AID (B)(4) REVISION G - NO FAILURES NOTED LINKED TO BLUNT TIPS. SINCE THE MANUFACTURE OF THIS BATCH OF NEEDLES IN APRIL 2023, THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH LOT 150/23/T FOR BLUNT TIPS. THERE HAVE BEEN NO OTHER COMPLAINTS ON A LOT MANUFACTURED IN 2023 TO DATE FOR BLUNT TIPS OR PAINFUL INSERTION. FROM THIS INVESTIGATION, THE DEVICE HISTORY 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. FAILURE CONFIRMED: NO.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT#: (B)(4). RETURNS HAVE BEEN REQUESTED FOR INVESTIGATION/EXAMINATION. FURTHER INVESTIGATION TO BE CARRIED OUT.

    Description of Event or Problem · 0

    PART S53153, CONCENTRIC NEEDLES. CUSTOMER STATED THE NEEDLES ARE DEFECTIVE AND BELIEVE THEY ARE BAD, THEY SAID THAT THEY ARE VERY HARD TO INSERT AND VERY PAINFUL FOR THE PATIENT.

    Description of Event or Problem · 0

    PART S53153, CONCENTRIC NEEDLES. CUSTOMER STATED THE NEEDLES ARE DEFECTIVE AND BELIEVE THEY ARE BAD, THEY SAID THAT THEY ARE VERY HARD TO INSERT AND VERY PAINFUL FOR THE PATIENT.

    Description of Event or Problem · 0

    PART S53153, CONCENTRIC NEEDLES. CUSTOMER STATED THE NEEDLES ARE DEFECTIVE AND BELIEVE THEY ARE BAD, THEY SAID THAT THEY ARE VERY HARD TO INSERT AND VERY PAINFUL FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791507 TECA CONCENTRIC NEEDLES TECA CONCENTRIC NEEDLES IKT NATUS MANUFACTURING LIMITED S53153 15D/23/T

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown