BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKN IV3000

    MDR report key: 13060076 · Received December 22, 2021

    Report

    Report Number
    8043484-2021-02039
    Event Type
    Injury
    Date Received
    December 22, 2021
    Date of Event
    March 25, 2019
    Report Date
    February 4, 2022
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    B3: THE ACTUAL OCCURRENCE DATE IS UNKNOWN. FOR THE PURPOSE OF THIS REPORT WE HAVE USED THE DATE THE PUBLICATION OF THE LITERATURE ARTICLE AS THE OCCURRENCE DATE. B5: LITERATURE CITATION CAMPAGNA S, GONELLA S, BERCHIALLA P, RIGO C, MORANO G, ZERLA PA, FUZZI R, CORONA G, STORTO S, DIMONTE V, MUSSA B. A RETROSPECTIVE STUDY OF THE SAFETY OF OVER 100,000 PERIPHERALLY-INSERTED CENTRAL CATHETERS DAYS FOR PARENTERAL SUPPORTIVE TREATMENTS. RES NURS HEALTH. 2019 JUN;42(3):198-204. DOI: 10.1002/NUR.21939. EPUB 2019 MAR 25. PMID: 30912181. H10: ADDITIONAL INFORMATION THE COMPLAINT WAS RECEIVED AS A RESULT OF ISSUES BEING IDENTIFIED IN A LITERATURE ARTICLE AND ACCORDING TO THE ARTICLE THE PATIENTS EXPERIENCED EXIT-SITE INFECTION DURING TREATMENT WITH THE DEVICE. THE DEVICE WAS USED FOR TREATMENT AND WAS NOT RETURNED FOR ANALYSIS. WE HAVE NOT BEEN ABLE TO CONFIRM A RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE OR IDENTIFY A DEFINITIVE ROOT CAUSE. AS NO LOT NUMBER WAS PROVIDED IT WAS NOT POSSIBLE TO CARRY OUT A DEVICE HISTORY REVIEW A COMPLAINT HISTORY REVIEW ON THE PRODUCT FAMILY REVEALED A SMALL NUMBER OF SIMILAR INSTANCES IN THE LAST THREE YEARS. THE INSTRUCTIONS FOR USE AND RISK FILES, MITIGATE THE REPORTED ISSUE WITH NO UPDATES REQUIRED. A CLINICAL ASSESSMENT DETERMINED THAT WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION CANNOT BE PERFORMED. THE USERS OF THE REPORTED PRODUCT ARE ADVISED TO CONSULT THE IFU, TO PREVENT FUTURE OCCURRENCES OF THE REPORTED ISSUE. THIS GUIDE PROVIDES COMPREHENSIVE INSTRUCTIONS OF THE OPERATION, USE AND LIMITATIONS OF THE DEVICE, INCLUDING APPLICATION AND REMOVAL OF DRESSINGS AND SKIN PREPARATION PRIOR TO USE. THIS INVESTIGATION IS NOW COMPLETE, WITH NO CORRECTIVE ACTIONS REQUIRED. NO FURTHER ACTIONS BY SMITH AND NEPHEW ARE DEEMED NECESSARY AT THIS STAGE. HOWEVER, WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE. D4: CORRECTED CATALOG NUMBER.

    Description of Event or Problem · 0

    ON THE LITERATURE ARTICLE NAMED "A RETROSPECTIVE STUDY OF THE SAFETY OF OVER 100,000 PERIPHERALLY-INSERTED CENTRAL CATHETERS DAYS FOR PARENTERAL SUPPORTIVE TREATMENTS", THE AUTHORS OF THE STUDY REPORTED THAT, DURING TREATMENT OF PICC WITH A IV3000 DRESSING, 35 PATIENTS EXPERIENCED EXIT-SITE INFECTION. THE PICC WAS REMOVED, HOWEVER ADDITIONAL DETAILS ABOUT HOW THE INFECTION WAS TREATED AND HOW THE TREATMENT WAS CONCLUDED ARE UNKNOWN. PATIENTS OUTCOME IS UNKNOWN.

    Description of Event or Problem · 0

    ON THE LITERATURE ARTICLE NAMED "A RETROSPECTIVE STUDY OF THE SAFETY OF OVER 100,000 PERIPHERALLY-INSERTED CENTRAL CATHETERS DAYS FOR PARENTERAL SUPPORTIVE TREATMENTS", THE AUTHORS OF THE STUDY REPORTED THAT, DURING TREATMENT OF PICC WITH A IV3000 DRESSING, 35 PATIENTS EXPERIENCED EXIT-SITE INFECTION. THE PICC WAS REMOVED, HOWEVER ADDITIONAL DETAILS ABOUT HOW THE INFECTION WAS TREATED, HOW THE TREATMENT WAS CONCLUDED OUTCOME OF THE PATIENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964640 UNKN IV3000 TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown