BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC 5F DL CATHETER BASIC TRAY W/70CM NITINOL GW

    MDR report key: 12096073 · Received June 30, 2021

    Report

    Report Number
    3006260740-2021-02505
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    March 23, 2021
    Report Date
    June 10, 2021
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K051672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REEV3238 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED LOCAL PICCLINE SITE INFECTION. START DATE: (B)(6) 2021, END DATE: (B)(6) 2021. MODERATE SEVERITY AND LIKELY RELATED TO THE DEVICE (CATHETER) AND UNLIKELY RELATED TO THE PROCEDURE AND UNRELATED TO THE ACCESSORIES (GUIDEWIRE, STYLET). ACTION TAKEN: MEDICATION PRESCRIBED, HOSPITALIZATION, DEVICE REMOVED. OUTCOME: RECOVERED, NO SEQUELAE. THE PATIENT WAS PLANNED HOSPITALIZED ON (B)(6) 2021 TO CONTINUE HERE CHEMOTHERAPY. AT ADMISSION THE PICCLINE WAS INFLAMED. A CENTRAL BLOOD CULTURE AND A WOUND SWAB ON SAME DAY SHOWED A KOAGULASENEGATIVE STAPHYLOCOCCUS INFECTION. SHE WAS TREATED WITH SEVERAL ANTIBIOTICS: PIPERACILLIN 4G/TAZOBACTAM 0,5G I.V. 2X/D FROM (B)(6) 2021, ON (B)(6) 2021 ONLY 1X/D; COTRIMOXAZOL 960MG ORAL 1X/D ON (B)(6) 2021, 2X/D ON (B)(6) 2021 AND 1X/D ON (B)(6) 2021 AND THEN EVERY MONDAY AND THURSDAY (2X/D). ADDITIONALLY SHE GOT CEFOTAXIM 1G I.V. 1X/D ON (B)(6) 2021 AND 2X/D FROM (B)(6) UNTIL (B)(6) 2021. SHE SHOULD TAKE IN CEFPODOXIM 200MG 2X/D UNTIL (B)(6) 2021. HER NORMAL CONCOMITANT MEDICATION INCLUDES: ASS 100MG 1X1; AMLODIPIN 5MG 2X1; BISOPROLOL 10MG 1X1; DEKRISTOL 1000 IE 1X1; L-THYROX 50G 1X1; PANTOPRAZOL 40MG 1X1; TORASEMID 10MG 1X0,5; TINZAPARIN 3500 IE S.C. 1X1; THE PATIENT COULD RECOVERED DISCHARGED AT HOME ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988721 POWERPICC 5F DL CATHETER BASIC TRAY W/70CM NITINOL GW CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REEV3238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other