BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 FR DL POWERPICC WITH TLS, MAXIMAL BARRIER PRECAUTION KIT

    MDR report key: 1833683 · Received September 10, 2010

    Report

    Report Number
    3006260740-2010-00265
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    August 26, 2010
    Report Date
    August 26, 2010
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K051672
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A CHR REVIEW SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT CAME TO THE HOSPITAL FOR OUTPATIENT PLACEMENT OF A PICC LINE FOR ANTIBIOTIC TREATMENT OF AN INFECTION SECONDARY TO CARPAL TUNNEL SURGERY. IMMEDIATELY AFTER PROCEDURE WAS COMPLETE, SHE EXPERIENCED AN ANAPHYLACTIC REACTION. TIME OF REACTION WAS WITHIN 5 MINUTES OF DRESSING COMPLETION. PATIENT COMPLAINED OF FEELING "HOT" AND NOTABLE FLUSHING OF FACE AND TORSO WAS OBSERVED. IN ADDITION, PATIENT EXPERIENCED SNEEZING, SWELLING OF LIPS, MUCOUS MEMBRANES, AND THROAT, "HEAVY CHEST," TACHYCARDIA, AND ITCHY URTICARIA (HIVES) FORMED "IN FRONT OF OUR EYES." O2 SATS REMAINED IN 90S, BUT PICC LINE WAS DISCONTINUED IMMEDIATELY. PATIENT WAS GIVEN SOLU-MEDROL 120 MG AND BENADRYL 50 MG. PATIENT WAS KEPT IN HOSPITAL ON O2 AND TELEMETRY FOR OVERNIGHT OBSERVATION. AT TIME OF DISCHARGE, SWELLING OF LIPS AND HIVES HAD MOSTLY RESOLVED, AND WAS FREE OF OTHER SYMPTOMS. PATIENT HAS HISTORY OF ALLERGY TO PCN, IODINE, PERCOCET. PATIENT WAS ALREADY RECEIVING SOLU-MEDROL EVERY 6 HOURS FOR REACTION TO PERCOCET THE DAY BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5 FR DL POWERPICC WITH TLS, MAXIMAL BARRIER PRECAUTION KIT LJS C.R. BARD, INC. (BASD) REUG1327

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention