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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NAVILYST MEDICAL INC./ ANGIODYNAMICS, INC. NAMIC CLEARACIL; CONTRAST INJECTION LINE
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NAVILYST MEDICAL INC./ ANGIODYNAMICS, INC. NAMIC CLEARACIL; CONTRAST INJECTION LINE Back to Search Results
Catalog Number 91031303
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); No Code Available (3191)
Event Date 09/12/2017
Event Type  Injury  
Event Description
Pt was having a cardiac angiogram, all tubing and med rad injector was primed and back primed.Contrast was injected and pt started to lose b/p and hr and then coded.The patient was taken to icu on review of the cath films the next morning, it was determined that the patient had an air embolism.The tubing that had been used during the procedure had been discarded and the team was not able to inspect for damage or if connections were sealed after contrast had been injected through the tubing.The injector was removed from service and checked out and found to be working properly.
 
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Brand Name
NAMIC CLEARACIL
Type of Device
CONTRAST INJECTION LINE
Manufacturer (Section D)
NAVILYST MEDICAL INC./ ANGIODYNAMICS, INC.
marlborough ME 01752
MDR Report Key6922097
MDR Text Key89143973
Report NumberMW5072632
Device Sequence Number1
Product Code DQO
UDI-Device IdentifierH965910313030
UDI-PublicH965910313030
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 10/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2019
Device Catalogue Number91031303
Device Lot Number5058013
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Life Threatening; Disability;
Patient Age79 YR
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