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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, INC. ULTRA THREE-WAY STOPCOCK W/SWIVEL MALE LUER LOCK; FMG- STOPCOCKS AND MANIFOLDS

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SMITHS MEDICAL, INC. ULTRA THREE-WAY STOPCOCK W/SWIVEL MALE LUER LOCK; FMG- STOPCOCKS AND MANIFOLDS Back to Search Results
Catalog Number MX5311L
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
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
ULTRA THREE-WAY STOPCOCK W/SWIVEL 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 road
dublin OH 43016
Manufacturer Contact
pete hirte
1265 grey fox rd.
st. paul, MN 55112
6516287384
MDR Report Key4063104
MDR Text Key4735935
Report Number2183502-2014-00465
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 07/03/2014
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 Expiration Date10/11/2016
Device Catalogue NumberMX5311L
Device Lot Number2543614
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/03/2014
Device Age8 MO
Event Location Hospital
Initial Date Manufacturer Received 06/06/2014
Initial Date FDA Received07/07/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/01/2013
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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