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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 Problems Defective Component (2292); Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/31/2021
Event Type  malfunction  
Event Description
Information was received regarding an unspecified cadd disposable tubing. It was reported that the device stopped on the way home. The user returned back to the clinic. When she arrived back to the clinic there was white residue on her bag on the outside where the tubing went into the bag. The facility gave her a new pump and pharmacy put together a new cartridge and she has headed back home. There was no patient, or clinician injury associated with these occurrences. No further details provided at this time.
 
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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
MDR Report Key12553766
MDR Text Key274936649
Report Number3012307300-2021-09683
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 09/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/01/2021
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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