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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 3983998
Device Problems Fluid/Blood Leak (1250); Device Dislodged or Dislocated (2923)
Patient Problem Swelling (2091)
Event Date 09/27/2020
Event Type  Injury  
Event Description
Patient spontaneously called stating that her tubing is leaking and she can see it.Lot number 3983998; patient is going to try another lot while on the phone then she explained to rph that she had surgery last month (surgery already reported) and the swelling may have caused the port/line to dislodge.She thinks the line is coming out.Advised she needs to go the er; she will call 9-1-1.She said to have them attend to her quicker.She wanted to let her rxd know and if i could page, advised will do.Rph sent pt to emergency room: pt was seen at er later same day.Not sure if pt was admitted, no other information is known or was reported at this time.Did we replace the device? yes; did the pt have a backup device they were able to switch to? unk; if no, what was the pt instructed to do in able to continue their infusion? pt went to er; is the infusion life sustaining? yes; what is the outcome of the event? resolve? ongoing? unk.Reported to (b)(6) by pt/caregiver.
 
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Brand Name
CADD EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key10627976
MDR Text Key209995530
Report NumberMW5097051
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 09/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Lot Number3983998
Is the Reporter a Health Professional? Yes
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age34 YR
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