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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CODAN US CORP. CODAN TRIFURCATED EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR

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CODAN US CORP. CODAN TRIFURCATED EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number BC 301-SUB
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504)
Patient Problem Hypoglycemia (1912)
Event Date 04/28/2021
Event Type  Injury  
Event Description
Pt's tpn filter was found to be leaking tpn fluids into pt's bed, there was a puncture in the filter. It was found by rn caring for patient during linen change. Pt's blood sugar was checked and it was 52, the tpn trifurcate with filter was replaced and pt's sugar was re-check before next care time and it was 93. Fda safety report id # (b)(4).
 
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Brand NameCODAN TRIFURCATED EXTENSION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CODAN US CORP.
MDR Report Key11790010
MDR Text Key249704229
Report NumberMW5101227
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBC 301-SUB
Device Catalogue NumberREF97.6999
Device Lot Number73174
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 05/06/2021 Patient Sequence Number: 1
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