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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS, INC. MERIT MANIFOLD; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
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MERIT MEDICAL SYSTEMS, INC. MERIT MANIFOLD; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS Back to Search Results
Model Number K0900317P
Device Problems Hole In Material (1293); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/05/2017
Event Type  malfunction  
Event Description
During set up of a custom manifold, the tubing appeared to have a pin hole and was leaking.The same issue occurred with a different set up for the same device.No sterile conditions were broken, neither patient was harmed.Both devices and packaging retained.The devices will be returned to the cath lab after a week, where the vendor rep may pick up for assessment.
 
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Brand Name
MERIT MANIFOLD
Type of Device
ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MERIT MEDICAL SYSTEMS, INC.
1600 west merit pkwy.
south jordan UT 84095
MDR Report Key6618297
MDR Text Key76857393
Report Number6618297
Device Sequence Number1
Product Code DTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 05/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2017
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date11/30/2019
Device Model NumberK0900317P
Device Catalogue NumberK0900317P
Device Lot NumberH10655452
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/12/2017
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer05/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Treatment
N/A.; NOT APPLICABLE.
Patient Age73 YR
Patient Weight110
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