BEUDAMED
    FDA Adverse Event Other Summary report: N

    BAXTER BLOOD-PACK UNIT NUMBER 4R3337

    MDR report key: 809553 · Received June 8, 2006

    Report

    Report Number
    MW1041752
    Event Type
    Other
    Date Received
    June 8, 2006
    Date of Event
    May 25, 2006
    Report Date
    June 8, 2006
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    JKA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    AT THE BEGINNING OF A WHOLE BLOOD DONATION, THE DONOR COMPLAINED OF A TREMENDOUSLY PAINFUL VENIPUNCTURE. THE NEEDLE WAS REMOVED IMMEDIATELY, AND THE VENIPUNCTURE SITE WAS CLEANED AS USUAL WITHOUT NOTING ANYTHING ABNORMAL. THE DONOR CALLED THE BLOOD BANK THE NEXT DAY WITH PAIN, TINGLING, AND NUMBNESS IN THE ARM. THE MEDICAL DIRECTOR REQUESTED THAT THE DONOR COME TO THE HOSP FOR A PATHOLOGIST TO LOOK AT HER ARM, BUT SHE WAS NOT ABLE TOP COME BECAUSE SHE WAS LEAVING TOWN. HE FURTHER ADVISED HER TO SEEK MEDICAL TREATMENT IF THE SITUATION WORSENED ADVISING HER THAT THE COST OF TREATMENT WOULD BE COVERED IF SHE CAME TO THIS HOSP, BUT COULD NOT BE GUARANTEED IF SHE SOUGHT TREATMENT ELSEWHERE. THE FOLLOWING DAY, A FRIEND OF THE DONOR REMOVED A SMALL SLIVER OF METAL FROM THE DONOR'S ARM AT THE SITE OF THE VENIPUNCTURE. THE DONOR NOTIFIED THE BLOOD BANK OF THIS ON 5/30/06, AND STATED THAT HER ARM HAD IMMEDIATELY IMPROVED AFTER REMOVAL OF THE METAL FRAGMENT. THE DONOR WAS INSTRUCTED TO GO TO THE URGENT CARE CLINIC FOR EVAL WHERE AN X-RAY OF THE DONOR'S ARM VERIFIED THAT THERE WERE NO OTHER FRAGMENTS IN HER ARM. A F/U CALL WAS PLACED TO THE DONOR ON 6/5/06, AND HER ARM WAS MUCH BETTER. THE BLOOD BANK NOTIFIED THE PRODUCTS SURVEILLANCE DEPT AT BAXTER HEALTHCARE CORP ABOUT THE EVENT BY PHONE ON 5/31/06 AT 1330.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAXTER BLOOD-PACK UNIT NUMBER 4R3337 WHOLE BLOOD COLLECTION BAG SET JKA BAXTER HEALTHCARE CORP. * M05C30048

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other