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. SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET
  • 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. SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET Back to Search Results
Catalog Number MX5341LN
Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Separation Problem (4043)
Patient Problem Insufficient Information (4580)
Event Date 09/19/2023
Event Type  malfunction  
Manufacturer Narrative
H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Event Description
It was reported that during an injected scan, the white part of the "tap" detached, causing the iodine to spill onto the scan table.This caused a 3-4 minute delay in performing the diagnostic scan (hematoma on left lower limb).Adverse patient effects are unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SMALL BORE STOPCOCKS
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6250 shier rings road
dublin OH 43016
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key18488343
MDR Text Key333000837
Report Number1526863-2024-00001
Device Sequence Number1
Product Code FMG
UDI-Device Identifier10351688506771
UDI-Public10351688506771
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 01/10/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMX5341LN
Device Lot Number4421389
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/12/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-