BEUDAMED
    FDA Adverse Event Summary report: N

    BAXTER TUBING SET

    MDR report key: 2929087 · Received January 24, 2013

    Report

    Report Number
    1419106-2012-00022
    Date Received
    January 24, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 18, 2012
    Manufacturer
    BAXA CORPORATION
    Product Code
    NEP
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO PATIENT INVOLVED WITH THIS EVENT. A BAXTER GLOBAL PRODUCT SURVEILLANCE REPRESENTATIVE CONTACTED THE CUSTOMER AND WAS TOLD THEY FELT THE PARTICLE WAS LOCATED IN THE NON-BAXA / BAXTER DEVICE. THE MEDWATCH INFORMATION WAS FORWARDED TO THE OTHER DEVICE MANUFACTURER FOR THEIR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED THAT CHANGES THE CONTENT OF THIS REPORT, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    WE RECEIVED WRITTEN NOTIFICATION, POST MARKED (B)(4) 2012, FROM THE FDA INFORMING US OF MEDWATCH REPORT (B)(4), WHICH THEY RECEIVED FROM ONE OF OUR CUSTOMERS. THE REPORT DESCRIBED AN EVENT WHERE THE CUSTOMER FOUND A SLIVER OF WOOD WHEN WITHDRAWING SOLUTION FROM A HOSPIRA 500 ML CONTAINER AFTER FILLING IT WITH BAXTER NS 0.9% SODIUM CHLORIDE USING A BAXA 099 REPEATER PUMP AND #11 FLUID TRANSFER TUBING SET WHILE ADDING PFIZERPEN G. THE 099 REPEATER PUMP IS USED TO TRANSFER SOLUTIONS FROM INDIVIDUAL CONTAINERS INTO A FINAL SOLUTION CONTAINER. THE BAXTER GLOBAL PRODUCT SURVEILLANCE DEPARTMENT CONTACTED THE CUSTOMER BY EMAIL (B)(4) 2012 AND AGAIN (B)(4) 2013 BY TELEPHONE IN ORDER TO FURTHER INVESTIGATE THE OCCURRENCE. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AS THE PUMP IS USED IN A LABORATORY ENVIRONMENT AND IS NEVER CONNECTED TO A PATIENT. THE CUSTOMER STATED THAT UPON FILLING THE HOSPIRA CONTAINER THEY SAW A SLIVER OF WOOD (<1 CM) FLOATING ON TOP OF THE SOLUTION. THE CUSTOMER DID A CULTURE OF THE ITEM, WHICH WAS NEGATIVE. THE CUSTOMER STATED THAT THEY COULD NOT BE SURE WHERE THE SLIVER CAME FROM, BUT HIGHLY SUSPECTED IT WAS IN THE HOSPIRA CONTAINER. HE DID NOT BELIEVE THE FLUID TRANSFER TUBING SET WAS INVOLVED, AS IT WAS FLUSHED PRIOR TO THE START OF THE PROCESS AND WAS NOT RETAINED FOR FURTHER EVALUATION. INSPECTION OF THE OTHER CONTAINERS FOUND NO ADDITIONAL CONTAMINATION. BAXTER GLOBAL PRODUCT SURVEILLANCE FORWARDED A COPY OF THE MEDWATCH REPORT TO THE HOSPIRA COMPLAINT DEPARTMENT BY EMAIL (B)(4) 2013. HOSPIRA ACKNOWLEDGED RECEIPT OF THE INFORMATION BY TELEPHONE (B)(4) 2013. THERE WERE NO PATIENTS OR INJURIES INVOLVED WITH THIS EVENT. THERE IS NO INDICATION THAT BAXA / BAXTER DEVICES WERE DEFECTIVE OR MALFUNCTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34160 BAXTER TUBING SET FLUID TRANSFER TUBING SET NEP BAXA CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1