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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH LT
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MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH LT Back to Search Results
Model Number SL18P
Device Problem Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 11/17/2018
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated.
 
Event Description
Catheter split below hub.
 
Manufacturer Narrative
Device was implanted for one month and two weeks before the incident occurred.Engineer removed the extensions and lumen from the hub for closer inspection.A digital microscope was used to view lumen wall thickness inside of the hub.Engineers were looking for wall thinness as an indicator of improper manufacturing.Wall thickness was found uniform throughout the hub, and no cracks or tears could be identified.Therefore, root cause could not be attributed to the manufacturing processes.It is unknown what caused the incident to occur.The root cause cannot be determined.
 
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Brand Name
8F X 18CM HEMO-CATH
Type of Device
HEMO-CATH LT
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key8398769
MDR Text Key138093505
Report Number2518902-2019-00015
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00884908045444
UDI-Public884908045444
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial,Followup
Report Date 06/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberSL18P
Device Catalogue NumberSL18P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/05/2019
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/05/2019
Initial Date FDA Received03/07/2019
Supplement Dates Manufacturer Received02/05/2019
Supplement Dates FDA Received06/07/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight13
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