BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS

    MDR report key: 1935302 · Received December 21, 2010

    Report

    Report Number
    1820334-2010-00653
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    October 7, 2010
    Report Date
    November 17, 2010
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXP UNK AS LOT IS UNK. (B)(4). MANUFACTURE DATE: UNK AS LOT IS UNK. EVENT EVAL - STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ONE OF THE RESIDENT'S LEFT A MESSAGE WITH THE AREA REP, ASKING ABOUT ALLERGIC REACTIONS ON COOK'S SPECTRUM CENTRAL VENOUS CATHETERS. WHEN THE AREA REP SPOKE WITH THE INDIVIDUAL, IT WAS REPORTED THAT THE CVC LINE WAS PLACED IN THE PT WITHOUT A PROBLEM; HOWEVER, A SWELLING OF THE NECK ON THE LEFT SIDE WAS NOTICED. THE REP EXPLAINED THAT HE IS AWARE OF A SLIGHT CHANCE OF AN ALLERGIC REACTION AT THE SITE OF THE PLACEMENT (A LITTLE SWELLING). THE RESIDENT THEN ASKED FOR ANY LITERATURE REGARDING ALLERGIC REACTIONS. ADD'L INFO WAS RECEIVED ON 11/18/2010: THIS HOSPITAL HAS BEEN USING ABRM CVC'S FOR A FEW YEARS (APPROX 3 YEARS), IT WAS A RIGHT IJ PLACEMENT, WITHIN 24 HOURS THE PT HAD LEFT SIDE SWELLING OF THE NECK, CATHETER WAS REMOVED AS A PRECAUTION. PT IS DOING FINE NOW BUT THEY CAN'T CONFIRM IF IT WAS BECAUSE OF THE CATHETER REMOVAL OR OTHER INTERVENTIONS. THE FOLLOWING ADD'L INFO WAS THEN RECEIVED ON 11/22/2010: ON (B)(6) 2010, THE PT HAD AN ESOPHAGEAL BIOPSY, DILATATION BALLOON FOR ESOPHAGEAL OBSTRUCTION. ON (B)(6) 2010, HE HAD ESOPHAGEAL PERFORATION, SECOND TO ENDOSCOPY. PLACED AN RJ CENTRAL LINE AND THE PT BEGAN COMPLAINING OF SWELLING ON THE LEFT SIDE OF THE NECK. THIS CONTINUED THROUGHOUT THE NIGHT. ON (B)(6) HE HAD TO BE INTUBATED. THE SWELLING CONTINUED. ON (B)(6) 2010 THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR HIGHER CARE (NOT BECAUSE OF THE SWELLING, BUT DUE TO HIS NEEDING OTHER CARE DUE OTHER ISSUES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED TRIPLE LUMEN CENTRAL VENOUS DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention