BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC/ CVC SECURE

    MDR report key: 13588360 · Received February 23, 2022

    Report

    Report Number
    1030451-2022-00001
    Event Type
    Injury
    Date Received
    February 23, 2022
    Date of Event
    November 6, 2021
    Report Date
    March 18, 2022
    Manufacturer
    MEDICAL ACTION INDUSTRIES
    Product Code
    PEZ
    UDI-DI
    20809160020231
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED AND LOT NUMBER WAS NOT PROVIDED. PATIENT NUMBER 1 OF 3. PATIENT HAS HAD 2 PICC LINES PLACED WITHIN THE PAST FEW MONTHS. THE INITIAL LINE WAS PULLED ON (B)(6) 2021 DUE TO SKIN BEING SORE AND ACCUMULATING FLUID UNDER THE DRESSING. THE PATIENT WHEN TO ER SEVERAL TIMES FOR THESE ISSUES. WOUND CULTURE WAS NEGATIVE. ANOTHER LINE WAS PLACED, WHICH RESULTED IN SKIN BREAKDOWN AND DRESSING CHANGE TWICE A WEEK. SITE DISCONTINUED USE OF CHG DRESSING AND DIVERTED TO AN ALTERNATE DRESSING. THE PATIENT HAS IMPROVED. 3M HAS BEEN NOTIFIED AND IS COMMUNICATING DIRECTLY WITH THE PATIENT TO FURTHER INVESTIGATE. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE PICC DRESSING CHANGE CONVENIENCE KIT. THE COMPLAINT COMPONENT HOWEVER IS A TEGADERM DRESSING WITH CHG, MANUFACTURED BY 3M. IT IS VENDOR ITEM NUMBER 1839-2100K. SINCE THERE IS NO COMPLAINT LOT INDICATED, THE COMPONENT LOT IS ALSO UNKNOWN. ALL INFORMATION REASONABLY KNOWN AS OF 23FEB2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP MEDICAL DEVICE REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Additional Manufacturer Narrative · 0

    THE PRODUCT INVOLVED IN THE EVENT REPORT HAS NOT BEEN RETURNED AND A LOT NUMBER WAS NOT PROVIDED BY THE REPORTER. PATIENT NUMBER 1 OF 3. MEDICAL ACTION INDUSTRIES IS THE MANUFACTURER OF THE COMPLAINT PICC DRESSING CHANGE CONVENIENCE KIT. THE COMPLAINT COMPONENT HOWEVER IS A TEGADERM DRESSING WITH CHG, MANUFACTURED BY 3M. IT IS VENDOR ITEM NUMBER 1839-2100K. SINCE THERE WAS NO COMPLAINT LOT SPECIFIED, THE COMPONENT LOT IS ALSO UNKNOWN. THE INVESTIGATION FINDINGS FROM THE SUPPLIER 3M INDICATE THIS ISSUE WAS LIKELY NOT THE RESULT OF DEFECTIVE PRODUCT. PER THE SUPPLIER, THE PICTURES INDICATED THE ISSUE WAS LIKELY DUE TO IMPROPER OVERALL SITE MANAGEMENT. 3M DETERMINED THAT THE COMPLAINTS WERE NOT CONSIDERED REPORTABLE.3M STATED ON (B)(6), 2022, THAT A 3M APPLICATION ENGINEERING SPECIALIST/CLINICIAN AND A 3M SALES REP WOULD CONTACT THE REPORTER AND FURTHER EDUCATE THEM ON BEST PRACTICES FOR USING AND MAINTAINING THE 3M CHG PICC/CVC DRESSING ON PATIENTS. THE COMPLAINT IS NOW CONSIDERED CLOSED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2022 HAS BEEN INCLUDED IN THIS MEDICAL DEVICE REPORT. THE INFORMATION PROVIDED BY O&M HALYARD, INC. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO O&M HALYARD, INC. O&M HALYARD, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21 CFR 803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    MAI COMPLAINT NUMBER - (B)(4). PATIENT NUMBER 1 OF 3. PATIENT HAS HAD 2 PICC LINES PLACED WITHIN THE PAST FEW MONTHS. THE INITIAL LINE WAS PULLED ON (B)(6) 2021 DUE TO SKIN BEING SORE AND ACCUMULATING FLUID UNDER THE DRESSING. THE PATIENT WENT TO ER SEVERAL TIMES FOR THESE ISSUES. WOUND CULTURE WAS NEGATIVE. ANOTHER LINE WAS PLACED, WHICH RESULTED IN SKIN BREAKDOWN AND DRESSING CHANGE TWICE A WEEK. SITE DISCONTINUED USE OF CHG DRESSING AND DIVERTED TO AN ALTERNATE DRESS. THE SITE HAS NOW IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1672963 PICC/ CVC SECURE CENTRAL VENOUS CATHETER DRESSING CHANGE KIT PEZ MEDICAL ACTION INDUSTRIES 74564 UNKNOWN 20809160020231

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention