BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 13360026 · Received January 26, 2022

    Report

    Report Number
    2182318-2022-00001
    Event Type
    Malfunction
    Date Received
    January 26, 2022
    Report Date
    January 26, 2022
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, THIS REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. 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 PRELIMINARY INVESTIGATIONS HAVE YIELDED ZERO IDENTIFIED DEFECTS, FAILURES, OR ABNORMALITIES IN THE RECORDS OR ADDITIONAL TESTING THAT WERE CONDUCTED. 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

    IT WAS REPORTED BY VYGON, A MEDICAL DEVICE DISTRIBUTOR, THAT A SECUREMENT DEVICE THAT THEY DISTRIBUTE ON BEHALF OF TIDI IS MALFUNCTIONING DURING USE. THE SECUREMENT DEVICE IS DESIGNED TO ANCHOR THE PICC WINGS USING SCRATCH ADHESIVE. THE DISTRIBUTOR IS REPORTING THAT UPON RELEASE, EXCESSIVE GLUE RESIDUE IS OBSERVED, THUS PREVENTING SAFE HANDLING DURING REMOVAL. THE CARETAKER GLOVES REMAIN ATTACHED TO THE ADHESIVE, AND ABUNDANT SOLUTION IS NECESSARY TO REMOVE THE GLUE. THIS EXCESSIVE ADHESIVE RESULTS IN CARETAKER MANEUVERS THAT RISK DISLODGING THE PICC CATHETER. THE REPORTED MALFUNCTION IS THAT THE ADHESIVE FILM COMES OFF AND REMAINS ATTACHED TO THE FIXATION WINGS: WHEN CLOSING THE TWO WINGS, THEY STICK GLUE ON GLUE, AND WHEN OPENING THE FILM, IT DETACHES FROM THE PART ABOVE IT AND REMAINS COMPLETELY ATTACHED TO THE FIXING FLAPS. SEPARATION OF THE ADHESIVE, RESULTING IN THE PICC LINE GETTING STUCK IN/TO THE DEVICE, COULD RESULT IN UNINTENDED REMOVAL OF THE MEDICAL LINE. THESE EVENTS MAY INTERRUPT PATIENT TREATMENT AND MAY CONTRIBUTE TO PATIENT INJURY. AT THIS TIME, THERE IS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505709 TIDI PRODUCTS, LLC GRIP-LOK PICC / CVC SECUREMENT DEVICE WITH ADHESIVE KMK TIDI PRODUCTS, LLC 3601CVC 48186439

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown