BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10770726 · Received November 2, 2020

    Report

    Report Number
    2210968-2020-08534
    Event Type
    Injury
    Date Received
    November 2, 2020
    Report Date
    October 6, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS, AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: PEDIATR CRIT CARE MED 2019; 20:E480¿E488; DOI: 10.1097/PCC.0000000000002059.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE, 'TITLE: INNOVATION IN CENTRAL VENOUS ACCESS DEVICE SECURITY: A PILOT RANDOMIZED CONTROLLED TRIAL IN PEDIATRIC CRITICAL CARE'. AUTHORS: AMANDA J. ULLMAN, RN, PHD; DEBBIE LONG, RN, PHD; TARA WILLIAMS, RN, MNURS; KYLIE PEARSON, RN, GCPICU; GABOR MIHALA, MENG, GRADDIPBIOSTAT; ADRIAN C. MATTKE, FRACP, FCICM; FIONA MACFARLANE, FRCA, FANZCA; CLAIRE M. RICKARD, RN, PHD CITATION: PEDIATR CRIT CARE MED 2019; 20:E480¿E488; DOI: 10.1097/PCC.0000000000002059. THIS STUDY AIMED TO ESTABLISH THE FEASIBILITY OF A DEFINITIVE RANDOMIZED CONTROL TRIAL EXAMINING THE EFFECTIVENESS OF CURRENT, AND NEW TECHNOLOGIES TO SECURE CENTRAL VENOUS ACCESS DEVICES (CVAD) IN PEDIATRICS. BETWEEN FEBRUARY AND AUGUST 2016, 169 PATIENTS (MEAN AGE=38 MONTHS OLD) WERE RANDOMLY ASSIGNED TO RECEIVE ONE OF THREE CVAD SECUREMENT PROCEDURES: STANDARD CARE WITH BORDERED POLYURETHANE DRESSING; TISSUE ADHESIVE (TA) AND BORDERED POLYURETHANE DRESSING; AND INTEGRATED SECUREMENT AND DRESSING (ISD). ALL PATIENTS RECEIVED PRIMARY DEVICE SECURITY VIA PROLENE SUTURE (ETHICON) AND INFECTION PREVENTION VIA CHG DISC (BIOPATCH; ETHICON). REPORTED COMPLICATIONS INCLUDED DISLODGEMENT (COMPLETE) (N=2); DISLODGEMENT (PARTIAL) (N=4); SUSPECTED CVAD -ASSOCIATED BLOODSTREAM INFECTION (N=3); CONFIRMED CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION (N=1); LOCAL INFECTION (N=1); OTHER CVAD COMPLICATIONS (N=4); UNKNOWN CVAD COMPLICATION (N=2); ANY SKIN COMPLICATIONS (N=7); TEAR (N=4); RASH (N=3); BLISTER (N=2); BRUISING (N=1); BLEEDING (N=13) WHICH REQUIRED DRESSING CHANGE; LEAKAGE (N=6) WHICH REQUIRED DRESSING CHANGE; ALLERGY (N=1) WHICH REQUIRED DRESSING CHANGE; AND OTHER REASONS FOR DRESSING CHANGE (N=9). IN CONCLUSION, CVAD COMPLICATIONS AND FAILURE REMAIN PROBLEMATIC WITHIN PICUS. INNOVATION IN CVAD SECURITY IS WARRANTED, TO ENSURE THE SAFETY OF CHILDREN RELYING ON CVAD FUNCTION DURING CRITICAL ILLNESS. AN EFFICACY TRIAL OF CVAD SECUREMENTS IN PICU IS FEASIBLE, PROVIDED THERE ARE ADEQUATE RESOURCES TO RECRUIT, FOLLOW-UP PATIENTS, AND EDUCATION OF CLINICIANS REGARDING PRACTICE CHANGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234128 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention