BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 12562857 · Received October 1, 2021

    Report

    Report Number
    2182318-2021-00010
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Report Date
    September 3, 2021
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO INJURIES TO THE PATIENT OR CAREGIVER NOR MEDICAL INTERVENTION RESULTING FROM THIS EVENT. LOSS OF ADHESION MAY RESULT IN THE ACCIDENTAL REMOVAL OF THE MEDICAL LINES AND SUBSEQUENTLY COULD RESULT IN MEDICAL INTERVENTION SHOULD THIS MALFUNCTION WERE TO REOCCUR. THIS IS THE ONLY COMPLAINT FOR THIS PRODUCTION LOT. HISTORICAL COMPLAINT DATA WAS REVIEWED FOR THE PAST THREE YEARS AND FOUND (B)(4) TOTAL COMPLAINTS FOR SIMILAR SECUREMENT DEVICES FOR ADHESIVE FAILURES. THESE PRODUCTS HAVE A COMPLAINT RATE OF (B)(4) FOR THIS FAILURE YEAR-TO-DATE. EVALUATION OF RETURNED UNITS FROM THAT SAME LOT CONFIRMED THE REPORTED ISSUE. THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED AS THE ADHESIVE ITSELF ((B)(4)). THE MATERIAL SUPPLIER IS AWARE OF THIS ISSUE. BASED ON THE THREE TOTAL COMPLAINTS RECEIVED FOR THIS ISSUE AND 1.7 MILLION PIECES SOLD, THE COMPLAINT RATE FOR THIS FAILURE IS EXTREMELY LOW. ADDITIONALLY, THERE HAVE BEEN NO REPORTED INJURIES DUE TO THIS FAILURE. ALL COMPLAINTS ARE TRENDED AND REVIEWED BY MANAGEMENT ON A MONTHLY CADENCE. 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 BASED UPON RISK CONSIDERATIONS. (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CUSTOMER HAS HAD 3 REPORTS IN THE FIELD OF THE FOAM DELAMINATING FROM THE ADHESIVE WHILE IN USE SECURING NEONATAL CATHETERS. CUSTOMER REPORTS THAT THEY HAVE NEVER SEEN THIS BEFORE. NO INJURIES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456921 TIDI PRODUCTS, LLC GRIP-LOK PICC / CVC SECUREMENT DEVICE WITH ADHESIVE, KMK 5804.08-NSB 41182630

    Patients

    Seq Age Sex Outcome Treatment
    1