BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 5785851 · Received July 12, 2016

    Report

    Report Number
    1036844-2016-00339
    Event Type
    Malfunction
    Date Received
    July 12, 2016
    Date of Event
    May 12, 2016
    Report Date
    June 23, 2016
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAZ
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). THE DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION AT THIS TIME. THE MANUFACTURER WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4). A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. A REVIEW OF SALES HISTORY DATA WAS PERFORMED TO OBTAIN A LOT NUMBER. HOWEVER, NO RECORD COULD BE FOUND. THE IFU FOR THIS KIT, K-05502-100D; REV. 11, WAS REVIEWED AS A PART OF THIS COMPLAINT INVESTIGATION. THE IFU WARNS THE USER, "NEVER TUG OR QUICKLY PULL ON CATHETER DURING REMOVAL FROM PATIENT TO REDUCE RISK OF CATHETER BREAKAGE. DO NOT APPLY ADDITIONAL TENSION ON THE CATHETER IF CATHETER BEGINS TO STRETCH EXCESSIVELY. REPOSITION PATIENT TO OPEN THE VERTEBRAL INTERSPACES AND RE-ATTEMPT REMOVAL IF RESISTANCE IS ENCOUNTERED OR IF CATHETER STRETCHES EXCESSIVELY DURING REMOVAL. DURING EPIDURAL CATHETER REMOVAL, THE LITERATURE INDICATES A FORCE OF APPROXIMATELY 1/3 OF A POUND IS ALL THAT IS NECESSARY TO EXERT IF PATIENT IS PROPERLY POSITIONED IN THE RECOMMENDED LATERAL NEUTRAL POSITION." A CORRECTIVE ACTION IS NOT REQUIRED AT THIS TIME AS A POTENTIAL ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. OTHER REMARKS: COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORDS WERE NOT REVIEWED AS NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER AND NO SALES HISTORY RECORDS COULD BE FOUND. THEREFORE, THE POTENTIAL CAUSE OF THE CATHETER BREAKING COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT THE SAMPLE.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE PATIENT WAS IN LABOR AND EPIDURAL CATHETER WAS INSERTED TO ASSIST WITH LABOR. AT THE NORMAL INTERVAL, DISCONTINUATION OF THE CATHETER WAS ATTEMPTED. THE REGISTERED NURSE MET RESISTANCE WHILE ATTEMPTING TO DISCONTINUE THE CATHETER AND NOTIFIED THE REGIONAL ANESTHESIA PROVIDER ON CALL. HE ATTEMPTED TO REMOVE THE CATHETER BUT MET RESISTANCE. HE THEN FLUSHED THE CATHETER AND AGAIN ATTEMPTED TO REMOVE IT. AT THAT POINT, THE CATHETER BROKE. THE TIP OF THE CATHETER WAS RETAINED IN THE PATIENT'S L4-L5 REGION AS CONFIRMED BY X-RAY AND CT. LATER THAT DAY THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED CATHETER. IT WAS SUCCESSFULLY REMOVED AS CONFIRMED BY X-RAY. THE PATIENT WAS DISCHARGED TWO DAYS LATER FOLLOWING CONFIRMATION THAT PHYSICAL ASSESSMENT WAS WITHIN NORMAL LIMITS.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES THAT THE PATIENT WAS IN LABOR AND EPIDURAL CATHETER WAS INSERTED TO ASSIST WITH LABOR. AT THE NORMAL INTERVAL, DISCONTINUATION OF THE CATHETER WAS ATTEMPTED. THE REGISTERED NURSE MET RESISTANCE WHILE ATTEMPTING TO DISCONTINUE THE CATHETER AND NOTIFIED THE REGIONAL ANESTHESIA PROVIDER ON CALL. HE ATTEMPTED TO REMOVE THE CATHETER BUT MET RESISTANCE. HE THEN FLUSHED THE CATHETER AND AGAIN ATTEMPTED TO REMOVE IT. AT THAT POINT, THE CATHETER BROKE. THE TIP OF THE CATHETER WAS RETAINED IN THE PATIENT'S L4-L5 REGION AS CONFIRMED BY X-RAY AND CT. LATER THAT DAY THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR REMOVAL OF THE RETAINED CATHETER. IT WAS SUCCESSFULLY REMOVED AS CONFIRMED BY X-RAY. THE PATIENT WAS DISCHARGED TWO DAYS LATER FOLLOWING CONFIRMATION THAT PHYSICAL ASSESSMENT WAS WITHIN NORMAL LIMITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439948 EPIDURAL CATHETERIZATION KIT ANESTHESIA CONDUCTION KIT CAZ TELEFLEX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention