BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKING TITANIUM ADAPTER FOR PERITONEAL DIAL CATH

    MDR report key: 1802004 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02560
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    June 15, 2010
    Report Date
    July 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K894783
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). SINCE NO SAMPLE WAS AVAILABLE, THE COMPLAINT COULD NOT BE CONFIRMED AND CAUSE WAS UNDETERMINED. SINCE NO LOT NUMBER WAS PROVIDED, WE WERE UNABLE TO PERFORM A REVIEW OF BATCH RECORDS. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RJ3 BIOPSY FORCEPS WAS USED DURING A COLONOSCOPY PROCEDURE PERFORMED ON (B)(6), 2010. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL OF THE DEVICE, IT WAS NOTICED THAT THE SPECIMEN WAS MISSING FROM THE BIOPSY CUPS AND THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. AT THE END OF THE PROCEDURE IT WAS DISCOVERED THAT THE WORKING CHANNEL OF THE SCOPE WAS DAMAGED.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS (PD) REGISTERED NURSE (RN) WENT TO THE HOME PATIENT?S (HP) HOUSE AND FOUND THE PATIENT HAD DISCONNECTED THE TRANSFER SET FROM THE TITANIUM CATHETER ADAPTER. THE HP WAS ON HEAVY PAIN MEDICATION, SO WAS CONFUSED BY THE TRANSFER SET AND DISCONNECTED IT FROM THE CATHETER ADAPTER. THE PD RN DISCARDED THE TRANSFER SET, ATTACHED A NEW ONE, AND GAVE THE PATIENT PROPHYLACTIC TREATMENT. NO PROBLEMS WERE SEEN WITH THE TRANSFER SET OR CATHETER ADAPTER. THE PD RN DID NOT KNOW THE AGE OF THE TRANSFER SET, BUT CHANGED THEM EVERY 6 MONTHS WITHOUT FAIL IF IT DID NOT NEED TO BE CHANGED BEFORE. NO FURTHER INFORMATION COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LOCKING TITANIUM ADAPTER FOR PERITONEAL DIAL CATH SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR