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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC CUSTOM MANIFOLD KIT; ADAPTOR STOPCOCK MANIFOLD

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MERIT MEDICAL SYSTEMS INC CUSTOM MANIFOLD KIT; ADAPTOR STOPCOCK MANIFOLD Back to Search Results
Catalog Number K09-05755
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/18/2015
Event Type  malfunction  
Event Description
Breakage of pressure tubing connector during set up for heart cath.Cath lab tech was tapping the end of a connector to clear air from the line and the connector just snapped off (broke off).Tubing discarded and new set-up obtained.No excessive force.This is the third similar event with this manufacturer's device within the last month.Previous product has been returned to the manufacturer for their review.
 
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Brand Name
CUSTOM MANIFOLD KIT
Type of Device
ADAPTOR STOPCOCK MANIFOLD
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS INC
1600 west merit pkwy.
south jordan UT 84095
MDR Report Key4846775
MDR Text Key18389915
Report Number4846775
Device Sequence Number1
Product Code DTL
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 05/26/2015
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 Other
Device Catalogue NumberK09-05755
Device Lot NumberH757571
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/12/2015
Event Location Hospital
Date Report to Manufacturer06/16/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/12/2015
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
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