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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information was received regarding a cadd cassette reservoir. It was reported that there were faulty cassettes. They stated that when they push the syringe containing the drug/diluent into the cassette, the medication leaks from the connector and within the cassette. They explained that it looked like the cassette popped from the inside. They can see solution outside of the cassette's inner bag. This is the 5th time it has happened since switching product. Patient had 2 mixes already made and they were going to try to make one more mix as backup, but they were concerned because they are having to waste drug due to the faulty cassettes. Patient's spouse was asked if they had extra cassettes that were of a different lot number, and they stated that they were all the same lot. They had a backup device for the life-sustaining infusion. There was no patient, or clinician injury associated with this occurrence.
 
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Brand NameCADD
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key12903283
MDR Text Key281503622
Report Number3012307300-2021-12046
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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