BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 13548729 · Received February 17, 2022

    Report

    Report Number
    2182318-2022-00003
    Event Type
    Malfunction
    Date Received
    February 17, 2022
    Report Date
    February 16, 2022
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THERE WAS NO PATIENT OR CAREGIVER INJURY AND NO MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. HISTORICAL COMPLAINT DATA WAS REVIEWED AND FOUND EIGHT TOTAL COMPLAINTS FOR SECUREMENT DEVICES FOR ADHESIVE THAT IS TOO STICKY SINCE 2018, FIVE OF WHICH WERE RECEIVED IN THE LAST 12 MONTHS. OF THE FIVE RECEIVED IN THE LAST 12 MONTHS, THREE WERE FOR DIFFERENT LOTS ASSOCIATED WITH THIS COMPLAINT. THESE DEVICES HAVE A COMPLAINT RATE OF 0.012% FOR THIS TYPE OF COMPLAINT DURING THAT TIME PERIOD. ON-HAND INVENTORY OF UNITS FROM DIFFERENT LOTS WAS REVIEWED AND FOUND NOT TO HAVE THE SAME ISSUE. ADDITIONALLY, SAMPLE RETAINS WERE TESTED FROM LOTS REPORTED AS DEFECTIVE BY CUSTOMERS AND NO FAILURES OR MALFUNCTIONS WERE IDENTIFIED. ALL INVESTIGATION AND TESTING HAS YIELDED ZERO IDENTIFIED DEFECTS, FAILURES, OR ABNORMALITIES IN THE RECORDS. AT THIS TIME, THERE IS NO REASON TO BELIEVE THIS IS A SYSTEMIC ISSUE. AT THIS TIME, THERE IS NOT ENOUGH EVIDENCE TO CONFIRM THAT A MANUFACTURING NON-CONFORMITY CONTRIBUTED TO THE REPORTED COMPLAINT, AND THE INSTRUCTIONS FOR USE WERE REVIEWED AND DETERMINED TO PROVIDE ADEQUATE INSTRUCTIONS AND WARNINGS FOR THE SAFE AND EFFECTIVE USE OF THE DEVICE. THEREFORE, NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY BASIS. AS PART OF THIS MONTHLY REVIEW, ANY EXCURSION ABOVE THE CONTROL LIMITS FOR THIS FAILURE MODE WILL BE ASSESSED, DOCUMENTED, AND ACTED UPON AS WARRANTED. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 0

    A COMPANY REPRESENTATIVE HAD REPORTED: 4 DAYS AGO, I TOOK A NEW 3601CVC LOT# 47580183 AND ATTACHED IT TO A CATHETER. I JUST NOW OPENED IT AS PER NORMAL DRESSING CHANGE PROCEDURE AND THERE IS SOME EVIDENCE OF DE-LAMINATION. DE-LAMINATION WHERE THE ADHESIVE ON THE UPPER FLAP OF THE 3601CVC REMOVES FROM THE BANDAGE MATERIAL AND ATTACHES ITSELF TO THE CATHETER HUB, LEAVING EXCESSIVE ADHESIVE ON THE DEVICE. EXCESSIVE ADHESIVE, RESULTING IN THE LINES GETTING STUCK IN/TO THE DEVICE MAY RESULT IN UNINTENDED REMOVAL OF THE MEDICAL LINES. THESE EVENTS MAY INTERRUPT PATIENT TREATMENT AND MAY CONTRIBUTE TO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861930 TIDI PRODUCTS, LLC GRIP-LOK PICC / CVC SECUREMENT DEVICE WITH ADHESIVE KMK TIDI PRODUCTS, LLC 3601CVC 49180015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown