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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CASSETTE MEDI RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Leak/Splash (1354); Product Quality Problem (1506)
Patient Problem Hypersensitivity/Allergic reaction (1907)
Event Type  Injury  
Event Description
Per spontaneous call from patient "patient stated that she has an allergy (symptom details unknown) to the dressing change tray central line and requested to remove that rx so that we dont send it out next time. Said that she is also having issues with the cassettes since the last couple of times (dates not reported) that they are leaking but pt has extras of those so pt said if it continues happening then she will call back to discuss with rph and said that she didn't want to speak to rph at the moment about it". Unknown if faulty supplies are available for investigation, lots and expiration dates were not reported. No additional information or dates reported. Reported to (b)(6) by: patient/caregiver.
 
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Brand NameCASSETTE MEDI RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key11848120
MDR Text Key251895416
Report NumberMW5101422
Device Sequence Number2
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/13/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received05/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device?

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