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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDCOMP 14.5FX24CM HEMO-FLOW CATHETER; HEMODIALYSIS CATHETER

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MEDCOMP 14.5FX24CM HEMO-FLOW CATHETER; HEMODIALYSIS CATHETER Back to Search Results
Model Number HFS24E
Device Problems Fluid/Blood Leak (1250); Torn Material (3024)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2014
Event Type  malfunction  
Event Description
Blood coming from tear in catheter lumen at entry site to skin.
 
Manufacturer Narrative
Received one intact 14.5f x 24 cm hemo-flow catheter for evaluation.A functional examination revealed a hole in the venous side of the lumen at the lumen to hub junction that leaks when the device is flushed.The hole is only visible when the lumen is manipulated away from the hub.A review of the mfg records for the device involved in the event was not possible as the lot number of the device was not provided.We are unable to determine the cause or factors that may have contributed to this event.An implanted catheter is exposed to many variables for which the mfr has no influence or control.These variables include but are not limited to: pt physiology, care and maintenance of the catheter by healthcare providers and the pt, exposure to site care agents and ointments, locking solutions, and off label uses such as medication admin.The longer the catheter is implanted and functioning properly the less likely a catheter's failure can be contributed to a mfg defect.The device involved in this event was implanted for 10+ months.
 
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Brand Name
14.5FX24CM HEMO-FLOW CATHETER
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MEDCOMP
harleysville PA
Manufacturer (Section G)
MEDCOMP
1499 delp dr.
harleysville PA 19438
Manufacturer Contact
susan smith, rn
1499 delp dr.
harleysville, PA 19438
2152564201
MDR Report Key3855688
MDR Text Key4681037
Report Number2518902-2014-00024
Device Sequence Number1
Product Code MSD
Combination Product (y/n)N
Reporter Country CodeEI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 04/21/2014
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 Health Professional
Device Model NumberHFS24E
Device Catalogue NumberHFS24E
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/03/2014
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 03/27/2014
Initial Date FDA Received04/22/2014
Was Device Evaluated by Manufacturer? Yes
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 Age71 YR
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