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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIODYNAMICS, INC. BIOFLO DURAMAX; CATHETER
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ANGIODYNAMICS, INC. BIOFLO DURAMAX; CATHETER Back to Search Results
Model Number BIOFLOW DURAMAX
Device Problems Fluid/Blood Leak (1250); Material Separation (1562)
Patient Problems Low Blood Pressure/ Hypotension (1914); Loss of consciousness (2418)
Event Date 03/17/2022
Event Type  Injury  
Event Description
During hemodialysis, the patient coughed, and the blue venous port of the catheter separated from the tubing, resulting in a large blood leak.Tubing was clamped off and the dialysis machine was stopped.A luer plug was forced into the end of the tubing to prevent further leakage.Patient then became hypotensive and lost consciousness.A code was called and emergency treatment was provided to save the patient.Later examination shows the tubing had a clean separation from the luer fitting.The luer fitting was not recovered, so it is not known whether a piece of tubing is attached to it or not.
 
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Brand Name
BIOFLO DURAMAX
Type of Device
CATHETER
Manufacturer (Section D)
ANGIODYNAMICS, INC.
26 forest st
marlborough MA 01752
MDR Report Key13994418
MDR Text Key288480134
Report Number13994418
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 03/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model NumberBIOFLOW DURAMAX
Device Catalogue NumberH965103029041
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/25/2022
Event Location Hospital
Date Report to Manufacturer04/04/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Required Intervention; Life Threatening;
Patient Age27740 DA
Patient SexMale
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