BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TIDI PRODUCTS, LLC GRIP-LOK

    MDR report key: 12930904 · Received December 4, 2021

    Report

    Report Number
    2182318-2021-00012
    Event Type
    Injury
    Date Received
    December 4, 2021
    Report Date
    December 3, 2021
    Manufacturer
    TIDI PRODUCTS, LLC
    Product Code
    KMK
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT WAS NOT RETURNED FOR EVALUATION. THIS REPORT IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER. MULTIPLE ATTEMPTS WERE MADE REQUESTING ADDITIONAL COMPLAINT INFORMATION. WITHOUT THE RETURN OF THE DEVICE NOR ADDITIONAL INFORMATION REGARDING THE EVENT, THE ROOT CAUSE COULD NOT BE DETERMINED. THE LOT NUMBER WAS PROVIDED AND THERE APPEAR TO BE NO ANOMALIES OR NONCONFORMANCES WHICH COULD HAVE CONTRIBUTED TO THIS EVENT NOTED IN THE DEVICE HISTORY RECORD FOR THIS LOT. HISTORICAL COMPLAINT DATA WAS REVIEWED AND FOUND NO OTHER SIMILAR COMPLAINTS FOR THIS PART. NO OTHER COMPLAINTS WERE RECEIVED IN RELATION TO THIS LOT NUMBER. THE INSTRUCTIONS FOR USE WERE REVIEWED AND APPEAR TO BE ADEQUATE FOR THE USE OF THIS PRODUCT. THEREFORE, NO ADDITIONAL CORRECTIVE OR PREVENTATIVE ACTIONS ARE NECESSARY AT PRESENT. 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 APPROPRIATE. MANUFACTURER REFERENCE FILE # (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER THERE WAS A BLEEDING FROM THE PICCLINE. THE PICCLINE WAS ON THE FLOOR AND THE PATIENT WAS BLEEDING. (PICCLINE APPLIED THE SAME DAY WITH THIS NEW DEVICE). INTENSE BLEEDING WITH NEED TO PUT A PRESSURE BANDAGE TO STOP THE BLEEDING. UPDATED COMPLAINT DESCRIPTION RECEIVED 11/15/2021: THE BLEEDING BANDAGE WAS STILL IN PLACE BUT THE PICC LINE UNDERNEATH WAS NO LONGER HELD AND THAT IS HOW HE ENDED UP ON THE GROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1828274 TIDI PRODUCTS, LLC GRIP-LOK PICC / CVC SECUREMENT DEVICE WITH ADHESIVE,, KMK TIDI PRODUCTS, LLC 5804.17 41172328

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Unknown Required Intervention