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., MEDEX¿ 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., MEDEX¿ SMALL BORE STOPCOCKS; STOPCOCK, I.V. SET Back to Search Results
Catalog Number MX5311L
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.There are two lot numbers that could be associated with this complaint lot numbers 3125601 and 3153895.
 
Event Description
This event occured in (b)(6).The customer reported that the stopcock was defective.Patient involvement is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MEDEX¿ SMALL BORE STOPCOCKS
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
SMITHS MEDICAL ASD INC.,
1265 grey fox rd
st. paul MN 55112
Manufacturer (Section G)
SMITHS MEDICAL ASD INC.,
1265 grey fox rd
st. paul MN 55112
Manufacturer Contact
michele seliga
1265 grey fox rd
st. paul, MN 55112
7633833052
MDR Report Key5750044
MDR Text Key48190815
Report Number2183502-2016-01276
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Reporter Occupation Health Professional
Type of Report Initial
Report Date 05/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMX5311L
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/26/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-