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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC CADD® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC CADD® EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7106-24
Device Problems Fluid/Blood Leak (1250); Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/11/2018
Event Type  malfunction  
Event Description
Information was received indicating that a smiths cadd® extension set leaked at the filter during administration.The extension set was replaced to resume therapy.Patient first suffered from under dose during infusion and then experienced overdose after changing infusion line.
 
Manufacturer Narrative
Device evaluation: one smiths medical cadd extension set was returned for analysis in a used condition.During analysis, visual inspection was performed, and no discrepancies were found.Leak test performed using hydrostat vessel and there was a leak detected in the air vent of the filter.Based on the evidence, the complaint was confirmed, and the problem source of the reported event is unknown.
 
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Brand Name
CADD® EXTENSION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8310230
MDR Text Key135160989
Report Number3012307300-2019-00331
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586023279
UDI-Public10610586023279
Combination Product (y/n)N
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/06/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/12/2023
Device Catalogue Number21-7106-24
Device Lot Number58X056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/11/2019
Date Manufacturer Received04/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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