BEUDAMED
    FDA Adverse Event Other Summary report: N

    PHERES-FLOW CENTRAL VENOUS CATHETER KIT

    MDR report key: 248985 · Received November 8, 1999

    Report

    Report Number
    1056436-1999-00157
    Event Type
    Other
    Date Received
    November 8, 1999
    Date of Event
    August 24, 1999
    Report Date
    August 24, 1999
    Manufacturer
    NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC.
    Product Code
    FJS
    Removal / Correction Number
    1056436-9/01/99-001R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 08/17/1999, DURING A ROUTINE INSPECTION OF A RETURNED PRODUCT (CATALOG #CV-332K, LOT #SE99107, THE INSPECTOR NOTED A BREACH (TWO (2) SMALL PINHOLES) IN THE PRODUCT'S STERILITY BARRIER. AT THAT TIME, A DETERMINATION COULD NOT BE MADE ON THE EXTENT OR CAUSE OF THE BREACH. ON 08/18/1999, AN INVESTIGARION WAS INITIATED TO DETERMINE THE EXTENT OF THE STERILE BARRIER BREACH. AN INVENTORY QUERY INDICATED APPROXIMATELY 3000 UNITS OF THE SAME CATALOG NUMBER IN STOCK. SAMPLES WERE OBTAINED BASED ON MIL-STD-1058 (125 UNITS). INSPECTION OF THE SAMPLES REVEALED FIVE (5) UNITS. WITH POTENTIAL BREACHES IN THE STERILE BARRIER. FURTHER INVESTIGATIONS WERE CONDUCTED (08/19/1999 THROUGH 08/23/1999) TO DETERMINE ROOT CAUSE OF THE BREACH (I.E. DEFECTIVE POUCH, COMBINATION OF INNER TRAY PACKAGING AND POUCH, COMBINATION OF PACKAGED UNITS AND SHIPPING CARTONS ETC.) AND EFFECT OF BREACH ON STERILITY. THE INVESTIGATION ENCOMPASSED ALL PRODUCTS PACKAGED IN A LIKE MANNER. SEVERAL TESTS WERE CONDUCTED AND CONCLUDED THAT THE PINHOLES WERE THE RESULT OF INTERACTION BETWEEN THE TOWER TEAR BAG AND THE INTERIOR OF THE SHIPPING CONTAINER. ON 08/26/1999, BASED ON THE RESULTS OF THE INVESTIGATION, A RECALL DETERMINATION WAS MADE FOR ALL PRODUCTS PACKAGED IN THE SAME MANNER. REFERENCE VOLUNTARY PRODUCT REMOVAL OF THE MFR'S DIALYSIS CATHETER KITS (REPORT NO. 4056436-9/01/99-001-R. ON 08/25/1999, THE MFR'S REPRESENTATIVES MET WITH FOOD AND DRUG ADMINISTRATION (FDA) PERSONNEL TO DISCUSS THE INVESTIGATION RESULTS AND PROPOSED CORRECTIVE ACTIONS. NO FURTHER DETAILS ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHERES-FLOW CENTRAL VENOUS CATHETER KIT CHRONIC SILICONE CATHETER FJS NEOSTAR MEDICAL TECHNOLOGIES/HORIZON MEDICAL PRODUCTS, INC. NA SE99107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other