BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 3899892 · Received June 27, 2014

    Report

    Report Number
    2183870-2014-00154
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 29, 2014
    Manufacturer
    COVIDIEN, LLC
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS CLOSUREFAST HAS BEEN PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ADDITIONALLY, THE STERILIZATION VALIDATION PERFORMED FOR THE CLOSUREFAST WAS REVIEWED BY THE COVIDIEN DIRECTOR OF MICROBIOLOGY AND STERILIZATION. A REVIEW OF THE CLOSUREFAST ROUTINE PRODUCTION PROCESS USED TO STERILIZE THE REPORTED DEVICES WAS PERFORMED. NO DISCREPANCIES OR ANOMALIES WERE FOUND ON EITHER REVIEW. BASED UPON THE ROUTINE STERILIZATION VALIDATION AND SUCCESSFUL ROUTINE PROCESSING, IT CAN BE CONCLUDED THAT THERE IS A HIGH CONFIDENCE THAT THE STERILIZATION PROCESS USED FOR THESE DEVICES RESULTED IN A STERILE PRODUCT. FURTHERMORE, IT WAS REPORTED THAT THE CATHETERS PERTAINING TO THE POTENTIAL SERRITIA CONTAMINATION (LOT # 552294) WERE SENT TO AN EPIDEMIOLOGY LAB FOR TESTING. THE LAB WAS UNABLE TO CULTURE ANY ORGANISM OFF THE COVIDIEN PRODUCT, WHICH WOULD POINT TO OTHER CAUSATIVE ISSUES UNSPECIFIED TO THE CLOSUREFAST DEVICES.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN (B)(4) LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN. A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    AS REPORTED: POST PROCEDURE WITH THE CLOSUREFAST DEVICE, 6 PATIENTS CONTACTED THE E.R. AND/OR HOSPITAL AND WERE ADMITTED BETWEEN (B)(6) 2014. THE PATIENTS WERE TREATED FOR A BACTERIAL INFECTION OF SERRATIA. THE PATIENTS WERE TREATED WITH IV ANTIBIOTICS AND LEVAQUIN. ADDITIONAL INFORMATION OBTAINED INDICATES THAT THE DEVICES INVOLVED DURING THE PROCEDURES WERE SENT TO THE EPIDEMIOLOGY LAB AT MANCHESTER HOSPITAL. THE INSPECTED CLOSUREFAST DEVICES WERE TESTED AND THE LAB COULD NOT CULTURE ANYTHING THAT WOULD SUGGEST EXPOSURE OF ANY ELEMENTS THAT MAY HAVE CONTRIBUTED TO THE REPORTED INFECTIONS. PER THE HOSPITAL, THE PRIMARY SOURCE OF THE BACTERIA COULD NOT BE CONFIRMED, BUT THE CLOSUREFAST DEVICES ARE NOT IN QUESTION. PLEASE REFERENCE MDRS 2183870-2014-00152, 2183870-2014-00153, 2183870-2014-00155, 2183870-2014-00156, AND 2183870-2014-00157 FOR THE OTHER CLOSUREFAST REFERENCED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377652 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN, LLC CF7-7-100 552294

    Patients

    Seq Age Sex Outcome Treatment
    1 Other