BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVER SOAKER 5IN (12.5CM): 40ML, DUAL 2+2 ML/HR

    MDR report key: 3184609 · Received June 20, 2013

    Report

    Report Number
    2026095-2013-00110
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    March 13, 2013
    Report Date
    May 23, 2013
    Manufacturer
    I-FLOW LLC
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE SAMPLE WILL BE RETAINED AT THE HOSPITAL AND NOT RETURNED TO I-FLOW. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: SHOULD THE DEVICE BE RETURNED TO THE MFR, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT. AT THIS TIME NO CONCLUSION CAN BE DRAWN AS TO WHAT CAUSED THE CATHETER TO BREAK AND REMAIN INSIDE THE PT. THE OBSERVED OCCURRENCE FOR THE REPORTED INCIDENT IS WITHIN THE ACCEPTABLE PROBABILITY. BASED ON CURRENT OBSERVATIONS THE RISK IS: AS LOW AS REASONABLY PRACTICABLE. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THIS INCIDENT HAS BEEN INCLUDED IN OUR COMPLAINT HANDLING DATABASE, WHICH IS ACTIVELY MONITORED AND TRENDED. (NOTE: THE REPORTED LOT NUMBER GIVEN WAS: 842680 FOR THE KIT, THE LOT NUMBER LISTED IS THE LOT NUMBER BELONGING TO THE CATHETER. THE EXPIRATION DATE LISTED IS THE EXPIRATION DATE LISTED ON THE KIT AS A WHOLE. THE DATE LISTED IS THE SHORTEST DATE OF EXPIRATION.) I-FLOW DID A DATABASE SEARCH FOR THE REPORTED INCIDENT DATED (B)(6) 2008. PER OUR RECORDS NO COMPLAINT WAS FOUND MATCHING THE REPORTED INFO. THIS IS THE FIRST TIME I-FLOW IS AWARE OF THIS INCIDENT.

    Description of Event or Problem · 1

    DRUG/DILUENT:UNK. FILL VOLUME: UNK. FLOW RATE: UNK. PROCEDURE: HERNIA REPAIR AND SCAR REVISION. CATHPLACE: UNK. ON (B)(6) 2013 DURING A HERNIA REPAIR AND SCAR REVISION PROCEDURE, A SEGMENT OF CATHETER WAS FOUND INSIDE THE PT MEASURING 30CM'S. IT WAS REMOVED BY THE PHYSICIAN. THE CATHETER WAS ORIGINALLY PLACED ON (B)(6) 2008 FOR A FLAP/ABDOMINOPLASTY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281208 SILVER SOAKER 5IN (12.5CM): 40ML, DUAL 2+2 ML/HR CATHETER BSO I-FLOW LLC 101372100 833782

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Other