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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CADD INTRAVASCULAR ADMINISTRATION SET

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CADD INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 21-7115-24
Device Problem Fluid Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 09/07/2021
Event Type  malfunction  
Event Description
Information was received regarding a cadd extension set. It was reported that the device was leaking at the end of the tubing where it attaches into the iv tubing. The end of the tubing was not straight, it seemed slightly crooked/curved. It is unknown if there was 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
MDR Report Key12628013
MDR Text Key276353773
Report Number3012307300-2021-09943
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K000942
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 Number21-7115-24
Device Catalogue Number21-7115-24
Device Lot Number4136394
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/20/2021
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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