BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IV3000

    MDR report key: 10228394 · Received July 3, 2020

    Report

    Report Number
    8043484-2020-01366
    Event Type
    Injury
    Date Received
    July 3, 2020
    Date of Event
    January 1, 1901
    Report Date
    February 10, 2021
    Manufacturer
    SMITH & NEPHEW MEDICAL LTD.
    Product Code
    KGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WE HAVE NOW CONCLUDED OUR INVESTIGATION FOR THE COMPLAINT RECEIVED. A REVIEW OF THE BATCH MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO PART OR LOT NUMBERS WERE PROVIDED, HOWEVER, THERE ARE NO INDICATIONS TO SUGGEST THAT THE DEVICE DID NOT MEET SPECIFICATIONS UPON RELEASE INTO DISTRIBUTION. THE COMPLAINT HISTORY FILE CONTAINS FURTHER INSTANCES RELATED EVENTS OF THE REPORTED EVENTS. THE DEVICE WAS INTENDED FOR USE IN TREATMENT. AS NO SAMPLES WERE RETURNED, A PRODUCT EVALUATION COULD NOT BE CARRIED OUT. DRESSINGS SHOULD BE CHANGED AROUND EVERY 3 DAYS BUT IN SOME CASES MAY BE LEFT IN PLACE FOR 7 DAYS. IF THE ADHESIVE INTEGRITY IS COMPROMISED DUE TO PROLONGED WEAR, THE SURGICAL SITE MAY BE SUSCEPTIBLE TO EXTERNAL CONTAMINATION.¿ A CLINICAL INVESTIGATION CONCLUDED; THE DATA PROVIDED IS FROM A CHINESE ARTICLE ON, ¿THE STUDY ON SAFETY AND EFFICACY OF HOME MAINTENANCE MODEL IN CANCER OUTPATIENTS WITH PICC.¿ ALL RELATED DOCUMENTS ARE UNDER THE MASTER COMPLAINT (B)(4). THE PROVIDED TRANSLATION WAS PRESENTED IN EXCEL SPREADSHEET IN ENGLISH. HOWEVER, WITHOUT CLINICALLY RELEVANT PATIENT-SPECIFIC SUPPORTING DOCUMENTATION, A THOROUGH MEDICAL INVESTIGATION COULD NOT BE PERFORMED. THE ROOT CAUSE OF THE INFECTION AND/OR PATIENT OUTCOME BEYOND THAT WHICH WAS DOCUMENTED IN THE ARTICLE COULD NOT BE CONFIRMED NOR CONCLUDED; THEREFORE, NO FURTHER MEDICAL ASSESSMENT IS WARRANTED AT THIS TIME. SHOULD ADDITIONAL MEDICAL INFORMATION BE PROVIDED THIS COMPLAINT WILL BE RE-ASSESSED. AS THE PRODUCT CODE IS UNKNOWN, A REVIEW OF THE DEVICE LABELLING COULD NOT BE CARRIED OUT. THE ASSOCIATED RISK FILE CONTAINS THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    SMITH & NEPHEW, INC. IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED UPON INFORMATION WHICH SMITH & NEPHEW, INC. HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, SMITH & NEPHEW, INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, SMITH & NEPHEW, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN A CLINICAL OBSERVATION OF "STUDY ON SAFETY AND EFFICACY OF HOME MAINTENANCE MODEL IN CANCER OUTPATIENTS WITH PICC. IT WAS DOCUMENTED ON THE PAPER THAT THE IV3000 (SMITH & NEPHEW) WAS APPLIED TO 202 PATIENTS, 27 CASES PRESENTED PUNCTURE POINT INFECTION. IT IS UNKNOWN TREATMENT OF THIS COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692174 UNKNOWN IV3000 TAPE AND BANDAGE, ADHESIVE KGX SMITH & NEPHEW MEDICAL LTD. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1