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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET
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ICU MEDICAL, INC. 17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET Back to Search Results
Model Number MC9079
Device Problems Complete Blockage (1094); Defective Component (2292); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/23/2020
Event Type  No Answer Provided  
Event Description
A lot of air found between pointy end of filter and tubing.Patient's peripherally inserted central catheter (picc) line tubing has been having issues with air bubbles for the past few days.Troubleshooting by rn transport specialist (rnts) 2 days ago and iv pump was changed.No leaks or break in line.Chamber noted to be full, rn emptied half of chamber and was able to flick all of the air bubbles up towards chamber.Consider use of different tubing if available.Part of larger air in line trend.This air seems lower than others reported and may be more associated with defective filter - this patient has also had repeated blood backup issues that are believed to be associated with a filter problem.This is all the information available.
 
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Brand Name
17" EXT SET W/0.2 MICRON FILTER, MICROCLAVE CLEAR, CLAMP, ROTATING LUER
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
ICU MEDICAL, INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key11404118
MDR Text Key234431486
Report Number11404118
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model NumberMC9079
Device Lot Number4915987
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/16/2021
Event Location Hospital
Date Report to Manufacturer03/03/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age30 DA
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