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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
Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Leak/Splash (1354)
Patient Problem Blood Loss (2597)
Event Date 02/10/2017
Event Type  malfunction  
Manufacturer Narrative
An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.
 
Event Description
Staff noticed blood leak and hole was noted on venous side of catheter just below hub.
 
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
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
1499 delp drive
harleysville PA 19438
Manufacturer (Section G)
MEDCOMP
1499 delp drive
harleysville PA 19438
Manufacturer Contact
1499 delp drive
harleysville, PA 19438
2152564201
MDR Report Key6560710
MDR Text Key75150619
Report Number2518902-2017-00020
Device Sequence Number1
Product Code MSD
UDI-Device Identifier00884908045444
UDI-Public884908045444
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 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
Device Operator Other
Device Model NumberSL18P
Device Catalogue NumberSL18P
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 04/14/2017
Initial Date FDA Received05/11/2017
Supplement Dates Manufacturer Received04/14/2017
Supplement Dates FDA Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age2 YR
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