BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANTIMICROBIAL PICC KIT 2-LUMEN: 5.5 FR X

    MDR report key: 1970292 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00006
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 11, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    LJS
    PMA / PMN Number
    K100635
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING USED ON MALE PT WITH SICKLE CELL ANEMIA. THE CATHETER WAS PLACED INTO THE PTS' RIGHT ARM. WITHIN FIVE MINUTES OF HAVING THE PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PLACED & TEGADERM PLACED ON SITE, THE PT HAD ITCHING & A RASH DEVELOPED ON BOTH ARMS & BODY; THE PT HAD HIVES. BENADRYL WAS ADMINISTERED & THE ITCHING SUBSIDED. THE PIC WAS LEFT IN PLACE. THE (B)(6) STATED THIS PT HAD FOUR ARROW COATED PICC'S PLACED OVER THE LAST SEVERAL MONTHS. THE PREVIOUS ONE GAVE HIM SOME REACTION AS WELL. THERE WAS NO DELAY IN TREATMENT & NO PT DEATH. THE PT OUTCOME WAS FINE. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2011, BY THE (B)(6) STATED THAT "THE PICC WAS PLACED FOR ANALGESIC THERAPY & POSSIBLE BLOOD TRANSFUSION. THERE WAS NO INSERTION DIFFICULTIES KNOWN & ALLERGIES ARE UNK. THEIR PROTOCOL FOR SKIN PREP IS WITH CHLORAPREP & AFTER THE INSERTION THEY PLACE A BIOPATCH & TEGADERM DRESSING. SHE DID NOT KNOW MUCH INFORMATION ABOUT THE PT FOR THEY ARE IN THE DEPARTMENT FOR A SHORT TIME FRAME JUST TO HAVE THE PICC PLACED. SHE REMINDED ME THAT THE (B)(6) LAWS INHIBITS HER FROM GIVING PT INFORMATION EVEN IF SHE DID KNOW." SEE MDR #1036844-2011-00007 FOR A RELATED EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANTIMICROBIAL PICC KIT 2-LUMEN: 5.5 FR X PERIPHERALLY INSERTED CENTRAL CATHETERS LJS ARROW INTERNATIONAL INC RV0105388

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other BENADRYL