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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. MEDEX¿ MICRO BORE T-CONNECTORS SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL, ASD, INC. MEDEX¿ MICRO BORE T-CONNECTORS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number BBF26
Device Problem Fluid Leak (1250)
Patient Problems Hypoxia (1918); Neonatal Deformities (1974)
Event Date 08/10/2017
Event Type  Injury  
Event Description
It was reported that there was a drop in oxygen saturation following use of a medex¿ micro bore t-connector. A critically ill patient was admitted at birth diagnosed with severe heart disease, most notably, no identifiable right ventricular cavity. Medication was being infused into the patient to maintain the patency of the ductus arteriosus. The ductus arteriosus is a blood vessel connecting the main pulmonary artery to the proximal descending aorta. Shortly after admission, the patient was noted to have a drop in oxygen saturation from the low 90s down to the high 70s. Careful inspection of the product noted a drop of fluid below the hub of the connector. The product was changed and the patient's oxygen saturation increased back to 94. The patient stabilized.
 
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Brand NameMEDEX¿ MICRO BORE T-CONNECTORS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
DUBLIN SSC
5200 upper metro place
suite 200
dublin OH 43017
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key6926945
MDR Text Key88914677
Report Number3012307300-2017-02160
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K841882
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/06/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/05/2020
Device Catalogue NumberBBF26
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/21/2017
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 Initial

Patient Treatment Data
Date Received: 10/07/2017 Patient Sequence Number: 1
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