BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLEX 33MM DURAPORE PVDF 0.22UM STERILE

    MDR report key: 1564806 · Received November 30, 2009

    Report

    Report Number
    8020892-2009-00001
    Event Type
    Malfunction
    Date Received
    November 30, 2009
    Manufacturer
    MILLIPORE IRELAND LTD
    Product Code
    JRL
    PMA / PMN Number
    K023892
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A STERILE SYRINGE FILTER. A HOLE IN THE FILTER MEMBRANE WAS OBSERVED BY END-USER PRIOR TO USE. THE UNIT WAS RETURNED AND EVALUATED. INVESTIGATION HAS DETERMINED THAT THE PUNCTURE TO THE MEMBRANE OCCURRED DURING THE MFR OF THIS LOT. MOST LIKELY ROOT CAUSE IS THAT, DUE TO THE STICKINESS OF THE MEMBRANES A BUILD UP OCCURRED ON THE ROBOT HANDLING OR PICKING HEADS. IF THE FORCE OF THE VACUUM IN THE MOULD, ACTING ON THE MEMBRANE COUPON AND THE OPPOSITE FORCE OF THE COUPON ATTACHED TO THE ROBOT HEAD DUE TO THE STICKY BUILD UP IS GREATER THAN THE TENSILE STRENGTH OF THE MEMBRANE, THEN A SECTION OF THE MEMBRANE MAY BE RIPPED FROM THE COUPON. THE DEFECT WAS NOT PICKED UP DURING THE 100% VISUAL HUMAN INSPECTION. A HEAD CLEANING REGIME AND AN AUTOMATED IN-LINE VISION SYSTEM HAVE BEEN INTRODUCED INTO THE MFG PROCESS AFTER THIS LOT WAS MANUFACTURED. INVESTIGATION HAS DEMONSTRATED THAT THE VISION SYSTEM WOULD HAVE REJECTED THIS UNIT. AS PREVENTATIVE ACTIONS, ADD'L MFG CONTROLS WILL BE INTRODUCED INCLUDING AN IN-LINE AIR INTEGRITY TESTER WHICH WILL 100% INTEGRITY TEST ALL MANUFACTURED UNITS.

    Description of Event or Problem · 1

    A COMPLAINT WAS REC'D FROM A (B) (6) CUSTOMER RELATING TO ONE UNIT OF STERILE MILLEX 33 UNIT 0.22UM DURAPORE PVDF SYRINGE FILTER ON (B) (6) 2009. THE COMPLAINT WAS IN REGARDS TO THE CUSTOMER OBSERVING A HOLE IN THE MEMBRANE OF THE FILTER. CUSTOMER OBSERVED THE HOLE PRIOR TO USE - NO ADVERSE INCIDENT OCCURRED. THE UNIT WAS RETURNED ON (B) (6) WITH THE COMPLAINT CONFIRMED ON (B) (6) 2009. THE CONTINUED USE OF THE PRODUCT MAY PRESENT A POSSIBLE HEALTH HAZARD, BECAUSE A NON-INTEGRAL MEMBRANE COULD ALLOW THE PASSAGE OF VIABLE OR NON-VIABLE CONTAMINANTS TO PASS THROUGH THE FILTER. AS A PRECAUTION, THE PRODUCT FROM LOT R8PN37631 IS BEING RECALLED FROM THE MARKETPLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLEX 33MM DURAPORE PVDF 0.22UM STERILE JRL (UNIT, FILTER, MEMBRANE) JRL MILLIPORE IRELAND LTD R8PN37631

    Patients

    Seq Age Sex Outcome Treatment
    1