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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IV SET TUBING; SET, I.V. FLUID TRANSFER
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IV SET TUBING; SET, I.V. FLUID TRANSFER Back to Search Results
Lot Number 22045804
Device Problems Obstruction of Flow (2423); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/03/2023
Event Type  malfunction  
Event Description
Iv gravity set tubing kinked below check valve.
 
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Brand Name
IV SET TUBING
Type of Device
SET, I.V. FLUID TRANSFER
MDR Report Key16113997
MDR Text Key306908774
Report NumberMW5114209
Device Sequence Number1
Product Code LHI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 01/04/2023
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? Yes
Device Operator Health Professional
Device Lot Number22045804
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/05/2023
Patient Sequence Number1
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