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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 or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/20/2015
Event Type  malfunction  
Event Description
Cath lab tech setting up for routine heart cath.Manifold set-up in progress and when tapping ao connector to remove air from line the connector broke off.This is the second tubing set that has broken in the same place during same procedure.Tech says that both times she was tapping gently on connector when it broke.No excessive force used on either device.
 
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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 parkway
south jordan UT 84095
MDR Report Key4797603
MDR Text Key5854603
Report Number4797603
Device Sequence Number2
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
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Catalogue NumberK09-05755
Device Lot NumberH757571
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/26/2015
Event Location Hospital
Date Report to Manufacturer05/27/2015
Initial Date Manufacturer Received Not provided
Initial Date FDA Received05/26/2015
Patient Sequence Number1
Treatment
NO OTHER THERAPIES
Patient Age42 YR
Patient Weight136
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