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U.S. Department of Health and Human Services

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

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CADD EXTENSIN SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4091220
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Spontaneous report from patient advising of leaky tubing, 2 out of 4 are leaking. Cadd extension set lot number 4091220. No other information known. Did the reported product fault occur while in use with the pt? no; did the product issue cause or contribute to pt or clinical injury? no; is the actual device available for investigation? no; did we [mfr] replace the device? yes; did the pt have a backup device they were able to switch to? yes; was the pt able to successfully continue their infusion? yes; is the infusion life-sustaining? yes. Reported to (b)(6) by pt/caregiver.
 
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Brand NameCADD EXTENSIN SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
MDR Report Key12662629
MDR Text Key277666572
Report NumberMW5104753
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Type of Report Initial
Report Date 05/03/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received10/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4091220
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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