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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: KIMBERLY CLARK / IFLOW ON-Q C BLOC; PORT-A-CATH
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KIMBERLY CLARK / IFLOW ON-Q C BLOC; PORT-A-CATH Back to Search Results
Model Number C66007
Device Problems Disconnection (1171); Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem Confusion/ Disorientation (2553)
Event Date 02/21/2014
Event Type  Injury  
Event Description
Pt was a port-a-cath for ongoing cancer treatment.After surgery, an on-q c-bloc (model 6007) was filled with ropivacaine 0.2%.Over the night, the pt became confused and disconnected iv and on-q lines.When the nurse reconnected the line, the on-q was inadvertently connected to the port-a-cath because the luer-lock end is similar to the iv connector.The pt received intravenous ropivacaine for approx 8 hrs before the mistake was noticed.The error was noticed by the next shift and corrected.No harm to pt but pca conducted due to the potential for a threatening event.As part of the rca process, a recommendation was made to file a medwatch report.We recommend that the on-q device should have a connector that is clearly different than standard iv tubing since local anesthetic infusion with on-q is not intended for intravenous infusion.
 
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Brand Name
ON-Q C BLOC
Type of Device
PORT-A-CATH
Manufacturer (Section D)
KIMBERLY CLARK / IFLOW
MDR Report Key3770932
MDR Text Key16013604
Report NumberMW5035754
Device Sequence Number1
Product Code MEB
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 04/18/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberC66007
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/21/2014
Is This a Reprocessed and Reused Single-Use Device? Yes
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight103
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