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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXT SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21710624
Device Problem Backflow (1064)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Spontaneous; patient called and stated that there is blood in iv line/tubing. Advised patient to go to emergency room but she requested to speak with a field nurse first. Notified the field nurse to contact the patient as soon as possible. Doctor's office notified. No further information provided. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCADD EXT SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12681750
MDR Text Key278181549
Report NumberMW5104851
Device Sequence Number1
Product Code FPA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21710624
Was Device Available for Evaluation? No Answer Provided
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?
Type of Device Usage

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