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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEX ULTRA SMALL BORE STOPCOCK; FMG - INTRAVASCULAR ADMINISTRATION SET

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SMITHS MEDICAL ASD, INC. MEDEX ULTRA SMALL BORE STOPCOCK; FMG - INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MX2311L
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  Injury  
Event Description
Reference uf/importer # (b)(4).
 
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.
 
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Brand Name
MEDEX ULTRA SMALL BORE STOPCOCK
Type of Device
FMG - INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
dublin OH
Manufacturer (Section G)
SMITHS MEDICAL ASD
6250 shier-rings rd.
dublin OH 43016
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4290782
MDR Text Key17629744
Report Number2183502-2014-00874
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Type of Report Initial
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? No
Device Operator Health Professional
Device Catalogue NumberMX2311L
Was Device Available for Evaluation? No
Date Report to Manufacturer11/17/2014
Initial Date Manufacturer Received 10/27/2014
Initial Date FDA Received11/18/2014
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
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