Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7343-24
Device Problem Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd administration set could not be vented and sometimes would have up to 300ml remaining in the infusion bag.No patient consequences were reported.No adverse effects were reported.
 
Manufacturer Narrative
Other text: h3: one cadd administration set unit was received in decontaminated condition without its original packaging.The sample was visually inspected at 12" to 16" under normal conditions of illumination; no defects were observed.The unit was set for accuracy testing using a cadd pump legacy and a balance mettler toledo to look for unusual function.The unit passed the test; the complaint was unable to be confirmed or duplicated.There was no fault found with the returned sample.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11088255
MDR Text Key224094265
Report Number3012307300-2020-12808
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517191820
UDI-Public15019517191820
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7343-24
Device Catalogue Number21-7343-24
Device Lot Number3984193
Was Device Available for Evaluation? No
Date Returned to Manufacturer12/10/2020
Was the Report Sent to FDA? No
Date Manufacturer Received03/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-