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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 8F X 18CM HEMO-CATH; HEMODIALYSIS CATHETER
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MEDCOMP 8F X 18CM HEMO-CATH; HEMODIALYSIS CATHETER Back to Search Results
Model Number SL18P
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code Blood Loss (2597)
Date of Event 02/10/2017
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
Staff noticed blood leak and hole was noted on venous side of catheter just below hub.
 
Additional Manufacturer Narrative
The contract manufacturer reviewed the device history record, sample and leak testing process.It was noted that the lot of catheters in question was 100% leak tested and that all catheters passed prior to release.It was determined that the failure occurred after being released from their facility.
 
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Brand Name
8F X 18CM HEMO-CATH
Common Device Name
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
MDR Report Key6560710
Report Number2518902-2017-00020
Device Sequence Number1082895
Product Code MSD
UDI-Device Identifier00884908045444
UDI-Public884908045444
Combination Product (Y/N)N
Initial Reporter CountryUK
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) 08/30/2017
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 Model NumberSL18P
Device Catalogue NumberSL18P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2017
Initial Date Received by Manufacturer 04/14/2017
Supplement Date Received by Manufacturer04/14/2017
Initial Report FDA Received Date05/11/2017
Supplement Report FDA Received Date08/31/2017
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 Age2 YR
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