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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL INC. ULTRA THREE-WAY STOPCOCK W/ MALE LUER LOCK; FMG - STOPCOCKS AND MANIFOLDS
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SMITHS MEDICAL INC. ULTRA THREE-WAY STOPCOCK W/ MALE LUER LOCK; FMG - STOPCOCKS AND MANIFOLDS Back to Search Results
Catalog Number MX43660
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
User facility reported that the listed device became disassembled during use.There were no adverse effects to patient reported.
 
Manufacturer Narrative
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.
 
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Brand Name
ULTRA THREE-WAY STOPCOCK W/ MALE LUER LOCK
Type of Device
FMG - STOPCOCKS AND MANIFOLDS
Manufacturer (Section D)
SMITHS MEDICAL INC.
dublin OH
Manufacturer (Section G)
SMITHS MEDICAL
6250 shier-rings rd.
dublin OH 43016
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4268014
MDR Text Key17994868
Report Number2183502-2014-00861
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 11/11/2014
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? Yes
Device Operator Health Professional
Device Catalogue NumberMX43660
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer10/27/2014
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/11/2014
Event Location Hospital
Initial Date Manufacturer Received 10/23/2014
Initial Date FDA Received11/12/2014
Was Device Evaluated by Manufacturer? No
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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