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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL MD, INC. MEDEX SMALL BORE STOPCOCKS
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SMITHS MEDICAL MD, INC. MEDEX SMALL BORE STOPCOCKS Back to Search Results
Catalog Number MX5341L
Device Problem Leak/Splash (1354)
Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)
Event Date 05/07/2015
Event Type  Injury  
Event Description
A report was received explaining that the listed device was added to tubing between a patient and main tubing attached to a dialysis machine.After an unspecified time of use, blood was found leaking from the connection of the stopcock and tubing.The blood loss reportedly amounted to 100cc or 500cc.The patient required a hypotensive blood transfusion due to the loss.No permanent injuries 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
MEDEX SMALL BORE STOPCOCKS
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
dublin OH
Manufacturer (Section G)
SMITHS MEDICAL
6250 shier-rings road
dublin OH 43016
Manufacturer Contact
michele seliga
1265 grey fox rd.
st. paul, MN 55112
6516287604
MDR Report Key4827922
MDR Text Key15911512
Report Number2183502-2015-00396
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 Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 06/03/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberMX5341L
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/28/2015
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/03/2015
Distributor Facility Aware Date05/07/2015
Event Location Hospital
Initial Date Manufacturer Received 05/13/2015
Initial Date FDA Received06/03/2015
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
Patient Outcome(s) Required Intervention;
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