BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q SILVERSOAKER CATHETER

    MDR report key: 2891470 · Received December 6, 2012

    Report

    Report Number
    2026095-2012-00310
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    I-FLOW, LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A SAMPLE WAS RETURNED FOR EVALUATION AND INVESTIGATION. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN. CONCLUSION: THE SAMPLE WILL BE EVALUATED AND A FOLLOW-UP REPORT WILL BE FILED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.5%, FILL VOLUME: UNKNOWN, FLOW RATE: 2ML/HR, PROCEDURE: INGUINAL HERNIA REPAIR, CATHPLACE: UNKNOWN, PATIENT CONTACT: YES. IT WAS REPORTED THAT DURING INSERTION, AFTER MD TESTED CATHETER-LEAK WAS NOTICED. THE PHYSICIAN REMOVED THE CATHETER AND REPLACED IT WITH A NEW ONE. NO ADDITIONAL TREATMENT WAS NEEDED. PATIENT STATUS IS SATISFACTORY. (UPDATED INFORMATION RECEIVED VIA E-MAIL ON (B)(6) 2012, FROM INITIAL REPORTER) "WE THINK THE CATHETER HAS A SLIT THAT WAS NOT VISIBLE TO THE EYE. WHEN THE DOCTOR WENT TO FLUSH INITIALLY, THAT IS WHEN THE LEAK WAS NOTICED. THE CATHETER WAS IN THE PATIENT AT THE TIME AND IT SEEMED TO FUNCTION IN ALL OTHER NORMAL CAPACITY. SO, THE CATHETER STILL APPEARS TO BE "WHOLE" IT IS NOT BROKEN INTO 2 PIECES." THE CATHETER IS PACKAGED WITH THE PUMP AS A KIT. THE FOLLOWING INFORMATION APPLIES TO THE PUMP ONLY: (B)(4), THE LOT #: 0200567724, THE CATALOG 3: 101370100).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER CATHETER BSO I-FLOW, LLC UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR