BEUDAMED
    FDA Adverse Event Other Summary report: N

    PREPACKED CARTRIDGE, ORIGINAL, DISPOSABLE DISTRIBUTED BY GE HEALTHCARE CONTAININ

    MDR report key: 1828772 · Received August 30, 2010

    Report

    Report Number
    3003940942-2010-00001
    Event Type
    Other
    Date Received
    August 30, 2010
    Date of Event
    July 9, 2010
    Report Date
    August 30, 2010
    Manufacturer
    W.R. GRACE & CO. - CONN
    Product Code
    CBL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVIEW OF THE UF/IMPORTER REPORT# (B)(4) AND THE ADDITIONAL INFO AVAILABLE TO GRACE AT THIS TIME, WE HAVE DETERMINED THAT NONE OF ITEMS IDENTIFIED IN THIS COMPLAINT SUGGEST THAT THE DEVICE HAS MALFUNCTIONED. NOR IS THERE ANY EVIDENCE THAT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. AS SUCH, (B)(4) DOES NOT BELIEVE THIS IS A REPORTABLE EVENT UNDER FDA'S MEDICAL DEVICE REPORTING REQUIREMENTS (21 CFR PART 803) AND, THEREFORE, NO SUBMISSION IS REQUIRED. HOWEVER, OUT OF ABUNDANCE OF CAUTION AND SINCE (B)(4) UNDERSTANDS THAT INFO ABOUT THIS EVENT WAS ALREADY REPORTED TO FDA BY THE USER FACILITY INVOLVED, (B)(4) IS PROVIDING SUPPLEMENTAL INFO TO FDA TO SUPPORT THE VIEW THAT THIS EVENT IS NOT A DEVICE MALFUNCTION. THE DEVICE HISTORY RECORD FOR BATCH CZ01-P133-08 SHOWED THAT THE INITIAL CHECKS ON THE SEALING EFFICACY WERE COMPLETED SUCCESSFULLY PRIOR TO THE RUN START-UP. NEITHER THE PRODUCTION RECORDS NOR MAINTENANCE WORK ORDERS INDICATE ANY ISSUES WITH THE (B)(4) WELDER DURING THE PACKAGING OF THIS BATCH. WHILE THE DEVICE HISTORY RECORD FOR BATCH CZ01-P133-08 PROVIDED NO EVIDENCE OF ISSUES WITH THE (B)(4). (B)(4) ONLY SHIPS PALLETIZED CARTONS OF PREPACKED CARTRIDGES. THERE IS A GREATER POTENTIAL THAT LIDS MAY LOOSEN DURING SHIPMENT OF UNPALLETIZED OR INDIVIDUAL CARTONS OF PREPACKED CARTRIDGES. THE USE OF AN OVER-PACK AND CUSHIONING REDUCES THE POSSIBILITY OF DAMAGE TO UNPALLETIZED CARTONS OF PREPACKED CARTRIDGES AND ENSURES SAFE SHIPMENT. (B)(4) WILL SHARE THIS INFO WITH OUR CUSTOMERS. THE BATCH WAS MADE PRIOR TO THE INSTALLATION OF A (B)(4). IN ADDITION, WE HAVE IMPLEMENTED 100% INSPECTION OF EACH WELDED PART FOR WELD INTEGRITY. THERE HAVE BEEN NO COMPLAINTS RECEIVED RELATED TO THE SEALS OF THE LIDS SINCE THE INSTALLATION OF THE (B)(4). REVIEW OF THE DEVICE HISTORY RECORD FOR BATCH CZ01-P133-08 DOES NOT REFLECT ANY ISSUES WITH CRACKED PREPACKED CARTRIDGES DURING THE MANUFACTURE OF THIS PRODUCT. ADDITIONALLY, (B)(4) COMPLETED 100% RE-INSPECTION OF SEVERAL PALLETS OF MATERIAL MANUFACTURED BETWEEN JANUARY 12, 2010 AND JANUARY 27, 2010. SOME OF THE MATERIAL WAS SHIPPED TO THE DISTRIBUTOR AND SUBSEQUENTLY RETURNED TO (B)(4), AND SOME WAS MAINTAINED AT (B)(4) FACILITY IN INVENTORY AND NEVER SHIPPED TO CUSTOMERS. IN ALL CASES, THERE WERE ZERO CRACKED PREPACKED CARTRIDGES OBSERVED DURING THIS RE-INSPECTION PROCESS. THIS INDICATES THAT THERE WERE NO OBVIOUS PROBLEMS PRESENT DURING THE TIME PERIOD WHEN THE LOT IN QUESTION WAS PRODUCED. IT IS POSSIBLE THAT A PREPACKED CARTRIDGE MAY HAVE CRACKED DURING THE SHIPPING AND HANDLING PROCESS AFTER LEAVING (B)(4). THE NATURE OF SODASORB IS THAT IS FRIABLE AND CAN GENERATE DUST PARTICLES OR FINES WHEN THE PELLETS MOVE AGAINST EACH OTHER. THIS CAN OCCUR BECAUSE THE PRODUCT IS, BY DESIGN, HIGHLY POROUS. THE POROSITY IS NECESSARY TO ALLOW GAS TO PERMEATE THROUGHOUT THE PARTICLE FOR OPTIMAL ABSORPTION OF CARBON DIOXIDE (CO2). A PERFECTLY SMOOTH AND HARD PARTICLE WOULD NOT ALLOW THIS PERMEATION AND WOULD HAVE SIGNIFICANTLY REDUCED ABSORPTION CAPACITY FOR CO2. AS A RESULT, A BALANCE BETWEEN POROSITY AND HARDNESS IS NEEDED TO KEEP DUST AT A MINIMUM WHILE MAXIMIZING CO2 ABSORPTION. THESE CHARACTERISTICS ARE INTRINSIC TO ANY CO2 ABSORBENT BASED ON SODA-LIME.

    Description of Event or Problem · 1

    UF/IMPORTER REPORT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PREPACKED CARTRIDGE, ORIGINAL, DISPOSABLE DISTRIBUTED BY GE HEALTHCARE CONTAININ CBL - ABSORBENT CARBON DIOXIDE CBL W.R. GRACE & CO. - CONN M11173312 CZ01-P133-08

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DETAILS.| (B)(4) FOR ADDITIONAL| PLEASE REFER TO UF/IMPORTER REPORT#