BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 12557744 · Received September 30, 2021

    Report

    Report Number
    2182318-2021-00009
    Event Type
    Malfunction
    Date Received
    September 30, 2021
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THIS REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. INFORMATION REGARDING THE CIRCUMSTANCES THAT LED TO THE MIGRATED IV LINES WAS NOT PROVIDED. 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 FOUR TOTAL COMPLAINTS FOR SECUREMENT DEVICES FOR ADHESIVE THAT IS TOO STICKY SINCE 2018. THESE DEVICES HAVE A COMPLAINT RATE OF 0.007% FOR THIS TYPE OF COMPLAINT YEAR-TO-DATE. AT THIS TIME THERE, IS NO EVIDENCE 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 · 1

    IT WAS REPORTED THAT VARIOUS HOME HEALTH AGENCY NURSES VOICED CONCERNS OVER THE GRIP LOK DEVICE NOT WORKING AS WELL AS THE PRIOR SECUREMENT DEVICE. THE DEVICE WAS REPORTED TO STICK TO THE OCCLUSIVE DRESSING, MAKING THE STERILE PROCEDURE DIFFICULT. THE NURSES WERE SHARING THE GRIP LOK WAS NOT SECURING THE LINE AND THEY WERE WORRIED ABOUT MIGRATION AND LINE DISLODGEMENT. FROM (B)(6) OF 2021 THERE WERE 7 MIGRATED LINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1450523 TIDI PRODUCTS, LLC GRIP-LOK PICC / CVC SECUREMENT DEVICE WITH ADHESIVE KMK 3300MWA

    Patients

    Seq Age Sex Outcome Treatment
    1