BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PICC SET: 1-L 16 GA X 19 -1/2 (50 CM)

    MDR report key: 1884191 · Received June 11, 2010

    Report

    Report Number
    1036844-2010-00041
    Event Type
    Injury
    Date Received
    June 11, 2010
    Date of Event
    March 5, 2009
    Report Date
    March 18, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LJS
    PMA / PMN Number
    K930129
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVAL. ADD'L INFO: NO SAMPLE WAS RETURNED BY THE CUSTOMER FOR AN INVESTIGATION. IT WAS REPORTED THE CATHETER WAS INSERTED VIA THE BASILICA VEIN ON (B)(6)2009 AND IN LESS THAN 24 HRS, THE PT DEVELOPED PHLEBITIS IN THE LEFT ARM. ON (B)(6)2009, THE CATHETER WAS WITHDRAWN. THE IFU FOR THIS PRODUCT WARNS THAT THE PRACTITIONER MUST BE AWARE OF COMPLICATIONS ASSOCIATED WITH CENTRAL VEIN CATHETERS INCLUDING THROMBOSIS AND THAT CLINICAL CONDITIONS SUCH AS SUCH AS PREVIOUS VENOUS THROMBOSIS MAY LIMIT THE USE OF PICC CATHETERS. PRACTITIONERS ARE ALSO CAUTIONED TO BE AWARE OF THE RISK OF CHEMICALLY INDUCED THROMBOPHLEBITIS. THE PT'S MEDICAL HISTORY OR THE MEDICATIONS ADMINISTERED THROUGH THE CATHETER WERE NOT REPORTED. ADDITIONALLY, THE SIZE OF THE PT'S VESSEL AS COMPARED TO THE CATHETER USED MAY ALSO EFFECT THE THROMBOSIS DEVELOPMENT; THE HEIGHT AND WEIGHT OF THE PT WERE NOT PROVIDED. A DEVICE HISTORY RECORD REVIEW FOUND NO EVIDENCE TO INDICATE A MFG RELATED CAUSE. AS A RESULT, THE POTENTIAL CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THIS IS ONE OF 2 RECORDS REFLECTING MULTIPLE OCCURRENCES (B)(4). ADD'L OCCURRENCES ARE DOCUMENTED AS MDR #1036844-2009-00060. UNTIL JULY 27, 2009, MULTIPLE OCCURRENCES WERE REPORTED ON A SINGLE MDR. THEY ARE NOW REPORTED AS INDIVIDUAL EVENTS. ALL MULTIPLE OCCURRENCES FROM (B)(6) 2009 THROUGH (B)(6) 2009 ARE BEING REMEDIATED TO INCLUDE THE CORRECT NUMBER OF COMPLAINTS, MDRS, VIGILANCE, AND CANADIAN REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE CATHETER WAS INSERTED VIA THE BASILIC VEIN ON (B)(6)2009. IT WAS NOTED 48 HRS AFTER THE CATHETER INSERTION, THE PT DEVELOPED PHLEBITIS IN THE LEFT ARM. ON (B)(6)2009, THE CATHETER WAS WITHDRAWN AND A ANTICOAGULATION THERAPY WAS ADMINISTERED. THIS EVENT WAS CONFIRMED BY DOPPLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC SET: 1-L 16 GA X 19 -1/2 (50 CM) PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTERNATIONAL INC RF8069184

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention ANTIGOAGULATION THERAPY