BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EFFLUENT SAMPLE BAG

    MDR report key: 1970694 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01026
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A LABEL ISSUE. PER THE NURSE, THE PRODUCT WAS EXPIRED. SAMPLES WERE RETURNED TO BAXTER FOR COMPLAINT INVESTIGATION. UPON VISUAL INSPECTION, NO LABELING ISSUES NOTED. THE DATE SPECIFIED BY THE NURSE AS THE EXPIRATION DATE IS THE DATE THE LABEL WAS CREATED IN OUR DOCUMENTATION SYSTEM. THE COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. A BATCH REVIEW WAS PERFORMED ON THE ASSOCIATED LOT WITH NO ISSUES NOTED. LABELING REQUIREMENTS FOR THE PRODUCT WERE REVIEWED. THIS COMPLAINT DOES NOT INDICATE A PRODUCT DEFECT OR QUALITY FAILURE, BUT RATHER INDICATES A CUSTOMER PREFERENCE THAT THE EXPIRATION DATE IS PRINTED ON THE PRODUCT OR LABELING. RENAL QUALITY ENGINEERING, ALONG WITH PLANT MANUFACTURING/QUALITY PERSONNEL, WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS REQUESTED, BUT HAS NOT YET BEEN RECEIVED FOR EVALUATION. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AN RN (REGISTERED NURSE) CALLED CORPORATE PRODUCT SURVEILLANCE (CPS) TO REPORT UNKNOWN QUANTITY OF EFFLUENT SAMPLE BAG, LOT NUMBER H10H11065, IN WHICH ANOTHER NURSE DISCOVERED WHAT APPEARS TO BE AN EXPIRATION DATE OF AUG 03 ON THE PACKAGE ON 4-JAN-11. THE RN STATED THAT THE PRODUCTS HAS BEEN USED AND THAT NO INJURY OR ADVERSE EVENT WAS REPORTED. CPS QUALITY SPECIALIST (PSQS) ANSWERING THE CALL EXPLAINED TO THE RN THAT THE LOT NUMBER PULLS UP AN EXPIRATION DATE OF 31 DEC 2015 IN CPS'S DATABASE LOOKUP.ON 25 JAN 2011, PRODUCT SURVEILLANCE SPOKE WITH NURSE REGARDING THE EFFLUENT SAMPLE BAG AND THE EXPIRATION DATE. THE NURSE STATED THAT SHE ORDERS HER SUPPLIES FROM (B)(4) AND THAT THE EXPIRATION DATE APPEARS TO BE AUG 3. A SAMPLE IS AVAILABLE FOR EVALUATION. ARRANGEMENTS WERE MADE TO OBTAIN THE SAMPLE. THE NURSE CONFIRMED THAT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EFFLUENT SAMPLE BAG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME H10H11065

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE