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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
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Event Description
The patient reported that she was having some bleeding that was coming from the area around connection from her ultrasite valve and cadd ext set.The patient stated that her line was well fastened and she couldn't tell where the issue was coming from.The patient reported that she had already replaced her valve and line and everything seems to be working fine.The patient stated her main concern was that she had this issue about 3 weeks ago, but she never reported it and wanted to know if there have any reports of similar issues or if there was a recall of either item.Patient had no other questions/concerns at this time.The patient did not miss any doses as a result of issue.Adverse event dates are unknown.The outcome of this event is unknown as pt did not report event dates unknown as pt didn't report them.Lot number and expiration date are unknown.No further information is known or given.Reference report mw5148277.Reported to (b)(6) by: patient/caregiver.
 
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Brand Name
CADD EXT SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key18170988
MDR Text Key328693038
Report NumberMW5148278
Device Sequence Number1
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 11/12/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/17/2023
Patient Sequence Number1
Treatment
FLOLAN SDV.; FLOLAN STERILE DILUENT (50ML).; PUMP CADD LEGACY.; ULTRA SITE 2 WAY CAPLESS VAL.
Patient SexFemale
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