BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER

    MDR report key: 1641272 · Received March 25, 2010

    Report

    Report Number
    2026095-2010-00022
    Event Type
    Other
    Date Received
    March 25, 2010
    Date of Event
    February 15, 2010
    Report Date
    February 16, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND PRODUCT EVALUATION. RECEIVED TWO ANTIMICROBIAL CATHETERS FOR EVALUATION AND INVESTIGATION. BOTH CATHETERS RECEIVED HAD EVIDENCE OF BEING SECURED AT THE MIDBODY SECTION. CATHETER NO. 1 BROKE OFF NEXT TO THE POINT OF SUTURE. THE INFUSION SEGMENT OF CATHETER NO. 1 WAS NOT RECEIVED FOR EVALUATION. CATHETER NO. 2 HAD A PERFORATION IN BETWEEN TWO SECTIONS THAT WAS NOT STRETCHED. THIS INDICATES THAT THE CATHETERS WERE SECURED INTO THE BODY, POSSIBLY WITH A STITCH OR STAPLE, OR CAUGHT ON SOMETHING IN THE BODY. INFORMATION RECEIVED DURING THIS INVESTIGATION CONFIRMED THAT RESISTANCE WAS MET PRIOR TO THE BREAKAGE. BASED ON THIS INFORMATION RECEIVED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER MOST LIKELY CONTRIBUTED TO THE REPORTED INCIDENT. THE ON-Q CATHETER DIRECTIONS FOR USE INCLUDE CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1306078, REV. C). IN ADDITION, I-FLOW HAS PREPARED A TECHNICAL BULLETIN IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." (1303971, REV. B). A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR CATHETER BREAK. IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO (B) (4) TISSUE COMPATIBILITY GUIDELINES FOR IMPLANTATION OF UP TO 30-DAYS; COMPLICATIONS MAY ARISE IF A CATHETER (OR PORTION THEREOF) IS LEFT IN THE BODY FOR LONGER THAN THIS PERIOD OF TIME. IF ADDITIONAL INFORMATION THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT REMOVED THE CATHETER ON (B) (6) 2010, AND IT BROKE DURING REMOVAL. RESISTANCE WAS ENCOUNTERED. FOLLOW-UP WITH THE DOCTOR'S OFFICE INDICATES THAT THE DISTAL PORTION OF THE CATHETER REMAINS IN THE PATIENT AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER BSO I-FLOW CORP. PM025-A 992891

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR