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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL INC. MINI DRIP IV TUBING - PRIMARY

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ICU MEDICAL INC. MINI DRIP IV TUBING - PRIMARY Back to Search Results
Model Number B59006
Device Problem No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/13/2016
Event Type  Malfunction  
Event Description

Mini drip iv tubing - 133 in appx 17. 2ml, 60 drop primary, 2 bravo24; 2 102, 24 hr use only. Pre-op nurse spiked iv fluid bag with iv tubing spike. Fluid filled iv tubing drip chamber. Fluid would not flow. Nurse confirmed all clamps open, no kinks in tubing. Attempted to flush with syringe without success. Iv fluid discarded.

 
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Type of DeviceMINI DRIP IV TUBING - PRIMARY
Manufacturer (Section D)
ICU MEDICAL INC.
951 calle amanecer
san clemente CA 92673
MDR Report Key5801912
MDR Text Key49830785
Report NumberMW5063458
Device Sequence Number1
Product Code LHI
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberB59006
Device LOT Number3272354
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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