BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 2251019 · Received September 12, 2011

    Report

    Report Number
    1820334-2011-00495
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 16, 2011
    Manufacturer
    COOK, INC.
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE. NO PRODUCT WAS RETURNED TO ASSIST IN INVESTIGATION. THE PROVIDED INSTRUCTIONS FOR USE STATES THE FOLLOWING: "POSSIBLE ALLERGIC REACTIONS OR ACCESS SITE INFECTION SHOULD ALWAYS BE CONSIDERED. A STERILE INFLAMMATORY RESPONSE POSSIBLY ASSOCIATED WITH THE USE OF THE PRODUCT IN CONJUNCTION WITH LATEX AND POWDERED NON-LATEX BASED GLOVES HAVE BEEN REPORTED WITH THE USE OF THIS PRODUCT." PER SPECIFICATION, QUALITY CONTROL PERSONNEL VERIFIED LUBRICITY AND DURABILITY OF DEVICE IS SUFFICIENT. WE ARE AWARE OF THE POTENTIAL FOR STERILE INFLAMMATORY RESPONSE; HOWEVER, WITHOUT A PATHOLOGICAL REPORT FROM THE DESCRIBED EVENT, IT IS DIFFICULT TO DETERMINE WITH CERTAINTY WHY THE FAILURE MODE OCCURRED. THE SKIN IRRITATION EXPERIENCED MAY BE A RESULT OF DEVICE USE IN CONJUNCTION WITH LATEX GLOVES THAT, WITHOUT TIMELY MEDICAL INTERVENTION, MAY HAVE DEVELOPED INFECTION. FURTHERMORE, FUNCTIONAL TESTING OF PRODUCT FROM SEVERAL LOTS RETURNED ON SIMILAR COMPLAINTS REVEALS THAT THE COATING IS PRONE TO SHED WHEN SUBJECTED TO CONTROLLED FRICTION CONDITIONS. ADDITIONALLY, RISK ASSESSMENT INDICATES THAT WITH THE ADDITION OF THIS COMPLAINT, RISK REDUCTION ACTIVITIES ARE RECOMMENDED AND, THEREFORE, CORRECTIVE ACTION HAS BEEN INITIATED. WE HAVE NOTIFIED APPROPRIATE INTERNAL PERSONNEL AND ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS. A CORRECTIVE ACTION WAS PREVIOUSLY ASSIGNED DUE TO PRIOR SIMILAR COMPLAINTS, IMPLEMENTED ON (B)(6) 2008 AND WAS VERIFIED EFFECTIVE ON (B)(6) 2008. RISK ANALYSIS INDICATED THAT WITH THE ADDITION OF THIS COMPLAINT, RISK REDUCTION ACTIVITIES ARE RECOMMENDED AND, THEREFORE, ADDITIONAL CORRECTIVE ACTION HAS BEEN INITIATED.

    Description of Event or Problem · 1

    THE PATIENT HAD AN INFLAMMATORY REACTION OVER THE INSERTION SITE REQUIRING ANTIBIOTICS. PATIENT OUTCOME WAS NOT PROVIDED BY REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK, INC. NA 2650850

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention