BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-Q CATHETER SILVERSOAKER 7.5 IN (19CM)

    MDR report key: 3960699 · Received June 20, 2014

    Report

    Report Number
    2026095-2014-00084
    Event Type
    Malfunction
    Date Received
    June 20, 2014
    Date of Event
    May 25, 2014
    Report Date
    May 25, 2014
    Manufacturer
    I-FLOW, LLC,
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: CUSTOMER DISCARDED THE SUSPECT PART AND WILL NOT BE RETURNING THE PRODUCT TO I-FLOW FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED. RESULTS: NO DEVICE WAS AVAILABLE FOR AN EVALUATION. PER THE DHR REVIEW THE LOT MEET ALL MANUFACTURING SPECIFICATIONS AT RELEASE. A HISTORICAL REVIEW WAS PERFORMED FOR 2.5 YEARS AND THERE WERE NO SIMILAR INCIDENTS REPORTED FOR MODEL PM050-A. SEE SCANNED PAGE. CONCLUSIONS: THE DEVICE WAS NOT RETURNED TO I-FLOW FOR EVALUATION AND ANALYSIS, THEREFORE WE ARE UNABLE TO DETERMINE A CAUSE FOR THE REPORTED EVENT. IF ADDITIONAL INFORMATION PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. INFORMATION FROM THIS INCIDENT HAS BEEN INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. TREND INFORMATION IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    PROCEDURE: CATHETER PLACEMENT AT IPSILATERAL RIB FRACTURE. CATHPLACE: PATIENT'S BACK. DATE OF PROCEDURE: (B)(6) 2014. THE NURSE REPORTED A SILVERSOAKER WAS BROKEN INTO 2 SEGMENTS DURING PATIENT USE. THE CATHETER WAS PLACED ON (B)(6) 2014 AND THE INCIDENT HAPPENED ON (B)(6) 2014. THE PATIENT IS A (B)(6) FEMALE WHO SUSTAINED A FALL RESULTING IN THREE FRACTURED RIBS ((B)(6)) ON THE LEFT SIDE. TWO SILVERSOAKER CATHETERS WERE PLACED ON THE PATIENT'S BACK FOR PAIN CONTROL. ONE OF THE CATHETERS WAS PLACED 3 CM LATERAL TO THE SPINE. ANOTHER WAS PLACED 6 CM LATERAL TO THE SPINE. A NURSE REPORTED THAT SHE HAD NOTICED SOMETHING WAS LEAKING WHEN SHE WALKED THE PATIENT TO THE BATHROOM. THE CATHETER CLOSER TO THE SPINE (3 CM LATERAL) WAS BROKEN OUTSIDE OF THE DRESSING. THE NURSE CONTACTED THE PHYSICIAN, WHO CAME TO REMOVE THE BROKEN CATHETER AND REPLACED IT WITH A NEW CATHETER. THE CATHETER DID NOT BREAK INSIDE THE PATIENT AND THE BROKEN EDGES WERE CLEAN CUTS WITHOUT STRETCHES. THE PATIENT IS DOING WELL WITH NO INJURIES. THE BROKEN CATHETER WAS THROWN AWAY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362423 ON-Q CATHETER SILVERSOAKER 7.5 IN (19CM) CATHETER, CONDUCTION, ANESTHETIC BSO I-FLOW, LLC, PM050-A 0201215393

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR