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

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.

• 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 Key: 3855688
• MDR Text Key: 4681037
• Report Number: 2518902-2014-00024
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: EI
• Number of Events Reported: 1
• 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 Number: HFS24E
• Device Catalogue Number: HFS24E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/03/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/27/2014
• Initial Date FDA Received: 04/22/2014
• 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 Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR