BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR URETHANE UMB CATH

    MDR report key: 4077725 · Received August 22, 2014

    Report

    Report Number
    1317749-2014-00311
    Event Type
    Malfunction
    Date Received
    August 22, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 14, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT SAMPLE WAS RETURNED TO THE MANUFACTURING SITE FOR REVIEW. IT WAS FOUND THAT THERE WAS A HOLE IN THE CATHETER AT THE BASE OF THE LUER FITTING. THE MANUFACTURING LOT NUMBER ASSOCIATED WITH THIS COMPLAINT WAS 360889 (JULIAN LOT NUMBER 317201X); IT WAS RELEASED ON 07/12/2013. THE DEVICE HISTORY RECORD (DHR) REVIEW INDICATED THAT THERE WAS NO QUALITY ISSUES ASSOCIATED WITH THIS DEFECT MODE. THE CUSTOMER REPORTED THAT THEIR PROTOCOL FOR CLEANING THE DEVICE INCLUDES THE USE OF CHLORHEXIDINE. CHLORHEXIDINE IS FREQUENTLY COMBINED WITH ALCOHOLS (ETHANOL AND ISOPROPYL ALCOHOL). THE CUSTOMER NOTED DIFFICULTY IN OBTAINING A BLOOD PRESSURE USING THE UVC CATHETER. IT IS LIKELY THAT EXTENSIVE TROUBLESHOOTING (REPORTED REPEATED FLUSHING AND REPOSITIONING OF THE CATHETER), PLACED STRESS ON THE CATHETER. THESE ACTIONS IN CONJUNCTION WITH THE USE OF ALCOHOL CLEANING PRODUCTS ON THE CATHETER ARE LIKELY TO HAVE CAUSED A HOLE BELOW THE CATHETER'S STRAIN RELIEF. THE LOT INVOLVED WITHIN THIS COMPLAINT WAS MANUFACTURED ON 06/20/2013 PRIOR TO IMPLEMENTATION OF SPECIAL 510K#K130725. UNDER SPECIAL 510K#K130725, COVIDIEN EXPANDED WARNINGS WITHIN THE INSTRUCTIONS FOR USE MANUAL OF THIS PRODUCT TO HIGHLIGHT THE CONCERN OF UVC CATHETER DAMAGE IN THE HUB AREA ASSOCIATED WITH THE USE OF ALCOHOL BASED DISINFECTANTS. THE INSTRUCTIONS FOR USE WERE REPLACED IN ALL STOCK, AND HOSPITALS WERE SENT A LETTER HIGHLIGHTING THIS ISSUE. IT MUST BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES: DO NOT USE INSTRUMENTS WITH SHARP OR ROUGH EDGES DIRECTLY ON THE CATHETER SINCE EVEN A MINOR CUT COULD TEAR OR BREAK THE...

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(4) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN UMBILICAL VESSEL CATHETER. THE CUSTOMER REPORTS THAT A 3.5F UAC WAS PLACED BY THE DR AT 0200. THE LINE HAD DIFFICULTY FROM THE BEGINNING READING A CORRECT BLOOD PRESSURE. THE CUSTOMER REPORTS THAT THEY SPENT TIME TROUBLESHOOTING THE LINE. THE CUSTOMER STATED THAT THEY REFLUSHED, REZEROED, AND REPOSITIONED THE LINE WITH NO IMPROVEMENT. THEY EVENTUALLY DECIDED TO REPLACE THE TRANSDUCER. AFTER REPLACING THE TRANSDUCER IT WAS DISCOVERED THAT THE UAC HAD SPLIT IN THE LINE NEAR THE HUB. BLOOD HAD BACKED UP THE LINE AND WAS LEAKING ON THE BED. THEY FOUND THIS WITHIN MINUTES AND THE BABY LOST LESS THAN 1 ML OF BLOOD. THE DR. WAS NOTIFIED IMMEDIATELY AND THE DR. REPLACED THE LINE. THE CUSTOMER FURTHER REPORTS THAT IT IS UNKNOWN WHAT WAS USED TO CLEAN THE AREA OR IF THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION; HOWEVER, THEIR PROTOCOL INCLUDES CHLORHEXIDINE. THE UAC WAS SECURED PER HOSPITAL PROTOCOL. THE UAC WAS INSERTED (B)(6) 2014 IN THE UMBILICUS. THE UAC WAS SET UP WITH A TRANSDUCER AND SALINE WAS USED TO FLUSH THE LINES PER THEIR STANDARD. IT IS UNKNOWN IF THE HUB WAS CLEANED. THE UAC WAS REPLACED THE SAME DAY THE LEAKING WAS DISCOVERED, (B)(6) 2014. THE UAC WAS REPLACED WITH THE SAME DEVICE. THE STATUS OF THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    508269 3.5FR URETHANE UMB CATH UMBILICAL VESSEL CATHETER FOS COVIDIEN 8888160333 317201X

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK