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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7364-24
Device Problem Leak/Splash (1354)
Patient Problem No Information (3190)
Event Date 12/04/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical tubing broke causing total parental nutrition (tpn) leakage when using a cadd solis pump.This in turn caused electrical failure of the pump and incomplete medication administration.The leak occurred at the plastic piece that connects to the pump at the end where the 2 teeth latch.
 
Manufacturer Narrative
Other, other text: there was one returned product.There was no damage nor workmanship defects were found.The complaint was unable to be confirmed and no fault was found with the returned product.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11114269
MDR Text Key225038834
Report Number3012307300-2021-00050
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517191776
UDI-Public15019517191776
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 03/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-7364-24
Device Lot Number3984056
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/08/2020
Initial Date FDA Received01/04/2021
Supplement Dates Manufacturer Received02/07/2021
Supplement Dates FDA Received03/08/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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