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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDEXMATRIX MANIFOLD WITH RIGHT MALE ROTATOR; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS PRODUCT CODE: DTL
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SMITHS MEDICAL ASD, INC. MEDEXMATRIX MANIFOLD WITH RIGHT MALE ROTATOR; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS PRODUCT CODE: DTL Back to Search Results
Catalog Number B1123-2MRCZ 
Device Problem Failure to Cycle (1142)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/04/2019
Event Type  malfunction  
Manufacturer Narrative
Report source: (b)(6).
 
Event Description
Information was received that during the use of a smiths medical medexmatrix manifold with right male rotator the "taps are not working correctly they are working back to front".No adverse patient effects were reported.
 
Manufacturer Narrative
Three medex manifolds were returned for analysis in good condition.Both white handle plugs were noted to have sign open instead of off embossed upon visual examination.Functional testing was not performed as a different type of plugs might result in different functionality.Inventory inspection performed with no defects found.Ncr log was reviewed with no discrepancies.Based on the evidence, the complaint was confirmed.However, the root cause was not found.
 
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Brand Name
MEDEXMATRIX MANIFOLD WITH RIGHT MALE ROTATOR
Type of Device
ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS PRODUCT CODE: DTL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key8489715
MDR Text Key141175505
Report Number3012307300-2019-01729
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date12/06/2021
Device Catalogue NumberB1123-2MRCZ 
Device Lot Number3333635
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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