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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR

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CADD ADMINISTRATION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7346-24
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/14/2021
Event Type  malfunction  
Event Description
Information was received indicating that during use of this smiths medical cadd administration sets, chemotherapy leaking at the filter site of the tubing was noticed. No patient injury reported.
 
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Brand NameCADD ADMINISTRATION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12624137
MDR Text Key276351513
Report Number3012307300-2021-09919
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K031361
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 10/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7346-24
Device Catalogue Number21-7346-24
Device Lot Number4143032
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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