BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET W/5 MICRON FILTER

    MDR report key: 2710025 · Received August 8, 2012

    Report

    Report Number
    9614279-2012-00011
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Date of Event
    July 10, 2012
    Report Date
    August 8, 2012
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FPA
    PMA / PMN Number
    K942988
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THREE UNUSED, UNOPENED SAMPLES WERE RETURNED FOR EVALUATION, HOWEVER, THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. THERE WERE NO MANUFACTURING DEFECTS VISUALLY NOTED ON THE UNUSED, UNOPENED SAMPLES. THE SAMPLES WERE TESTED FOR OCCLUSION AND FOR LEAKAGE PER SPECIFICATION. THERE WAS NO OCCLUSION OR LEAKAGE OBSERVED ON THE SETS. THE ISO LUER / TAPER TEST WERE PERFORMED ON THE FEMALE AND MALE ADAPTERS WITH ACCEPTABLE RESULTS. IN AN ATTEMPT TO SIMULATE THE REPORTED EVENT, THE SETS WERE ATTACHED TO A PRIMED IV ADMINISTRATION SET. THE EXTENSION SETS WERE THEN PRIMED AND THE ROLLER CLAMP CLOSED ON THE IV SET. A FEW DROPS OF RESIDUAL FLUID WERE INITIALLY OBSERVED FROM THE DISTAL END OF THE EXTENSION SET. THIS RESIDUAL FLUID IS DUE TO GRAVITY AND THE FACT THAT THE EXTENSION SET HAS A MICRON FILTER WITH AIR VENTS THAT WILL ALLOW THE RESIDUAL FLUID TO DRAIN OUT THE DISTAL CONNECTOR BELOW THE ROLLER CLAMPED SECTION OF THE IV ADMINISTRATION SET. NO LEAKAGE WAS OBSERVED AFTER THE RESIDUAL FLUID HAD DRAINED. THE REPORTED INCIDENT COULD NOT BE DUPLICATED AND THE SETS WERE FOUND TO BE ACCEPTABLE. IN A FOLLOW UP CALL TO THE FACILITY, THE REPORTER CONFIRMED THAT THERE WAS NO PT INJURY OR INTERVENTION NEEDED AS THE EVENT OCCURRED WHEN THE SET WAS BEING PRIMED. SHE ALSO CONFIRMED THAT THE LEAKING IS NOTED FROM THE DISTAL CONNECTOR WHEN THE EXTENSION SET IS ATTACHED TO THE IV SET. BATCH RECORD REVIEW OF THE REPORTED LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES OR NON CONFORMITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A REVIEW OF THE CUSTOMER COMPLIANT DATABASE REVEALED NO ADVERSE TRENDS OF THIS NATURE AGAINST THE REPORTED CATALOG NUMBER OR FINISHED GOOD LOT NUMBER. SINCE THE ACTUAL SAMPLE WAS NOT RETURNED, A THOROUGH INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE INVESTIGATION, NO SPECIFIC CONCLUSIONS CAN BE DRAWN REGARDING THE CAUSE OF THE EVENT, HOWEVER, IT IS LIKELY THAT THE LEAKING MAY BE ATTRIBUTED TO THE DRAINING OF THE RESIDUAL FLUID REMAINING IN THE LINE OF THE EXTENSION SET BELOW THE ENGAGED CLAMP OF THE IV ADMINISTRATION SET. IF THE ACTUAL SAMPLE IS RETURNED AND/OR ADDITIONAL PERTINENT INFO BECOMES AVAILABLE, A FOLLOW- UP REPORT WILL BE WRITTEN.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: PRODUCT ATTACHED TO IV ADMINISTRATION SET # NF3140. SOLUTION LEAKING OUT OF ONLY THE FILTER PRODUCT AFTER PRIMING, DESPITE CLAMP BEING CLOSED ON THE ADMINISTRATION SET. TWO EVENTS TODAY DURING PRIMING OF THE SET WITH CHEMOTHERAPY. THEY HAVE BEEN EXPERIENCING THIS ISSUE SINCE THE BEGINNING OF THE YEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXT SET W/5 MICRON FILTER EXTENSION SET FPA B. BRAUN DOMINICAN REPUBLIC NA 0061204503

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other