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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7308-24
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Date 11/27/2019
Event Type  malfunction  
Event Description
Information was received indicating that medication leaked out of a smiths medical cadd cassette reservoir when 200cc of anticancer agent was being filled with a syringe (4th of 4 syringes).There was no patient injury.Possible lot numbers are 3863367 and 3852998. .
 
Manufacturer Narrative
One reservoir cassette was returned for evaluation.Visual inspection of the device found it to be in good physical condition.Device underwent functional testing by using a syringe to detect for leaking in the cassette.During the test a leak was observed, confirming the reported customer allegation.The problem source has been determined to be either the bag was damaged during the assembly process due to a worn tool, or the bag was mishandled during the leak test during manufacturing.
 
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Brand Name
CADD CASSETTE RESERVOIR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9521120
MDR Text Key177144358
Report Number3012307300-2019-06994
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586032370
UDI-Public10610586032370
Combination Product (y/n)N
PMA/PMN Number
K081156
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 03/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/26/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number21-7308-24
Device Catalogue Number21-7308-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/04/2019
Date Manufacturer Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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