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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL MD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7359-24
Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)
Patient Problem Chemical Exposure (2570)
Event Date 06/20/2022
Event Type  malfunction  
Event Description
Patient called into the clinic to inform staff that the 5fu pump he has was beeping "air in line" patient was told to come to clinic and he arrived about 5:30pm.Tubing was found to have air and chemo was leaking from connection site closest to pump and had leaked on patient's clothes and inside the bag carry on bag provided for pump.5fu tubing was disconnected.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
6000 nathan ln n
minneapolis MN 55442
MDR Report Key15121225
MDR Text Key296785831
Report Number15121225
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027406
UDI-Public(01)10610586027406
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7359-24
Device Lot Number4257018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/12/2022
Event Location Hospital
Date Report to Manufacturer07/28/2022
Initial Date Manufacturer Received Not provided
Initial Date FDA Received07/28/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age18615 DA
Patient SexMale
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