• 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. SET, ADMIN, CADD, 108", SPIKE 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. SET, ADMIN, CADD, 108", SPIKE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7394-24
Device Problem Fluid Leak (1250)
Patient Problem Underdose (2542)
Event Date 01/30/2020
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical administration set was implicated in a leaking issue with a smiths medical pump. During administration of blinatumomab, a puddle of liquid on the floor was found during the infusion. They checked over the tubing but couldn't find an apparent leak. It should be noted that another iv bag with different tubing was also infusion at the time, so it couldn't definitely be linked to leaking tubing from the cadd administration set. No adverse events were reported due to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSET, ADMIN, CADD, 108", SPIKE
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, mn 
3833310
MDR Report Key9869666
MDR Text Key184632425
Report Number3012307300-2020-02177
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 03/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7394-24
Device Lot Number48X091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-