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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 HEMODIALYSIS CATHETER
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MEDCOMP 8F X 18CM HEMO-CATH; HEMO-CATH LT HEMODIALYSIS CATHETER Back to Search Results
Model Number SL18P
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 06/26/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.
 
Event or Problem Description
Catheter inserted without event.In situ for about 10 days when solution began to seep out of the catheter near the cuff.
 
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Brand Name
8F X 18CM HEMO-CATH
Common Device Name
HEMO-CATH LT HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key6750078
Report Number2518902-2017-00039
Device Sequence Number13616315
Product Code MSD
UDI-Device Identifier00884908045444
UDI-Public884908045444
Combination Product (Y/N)N
Initial Reporter CountryNZ
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 12/19/2017
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
Operator of Device Other
Device Expiration Date01/30/2020
Device Model NumberSL18P
Device Catalogue NumberSL18P
Device Lot NumberMBXL120
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2017
Initial Date Received by Manufacturer 06/30/2017
Supplement Date Received by Manufacturer06/30/2017
Initial Report FDA Received Date07/28/2017
Supplement Report FDA Received Date12/19/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age1 YR
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