MAUDE Adverse Event Report: MEDCOMP 14.5FX28CM PC HEMO-FLOW; HEMODIALYSIS CATHETER

Model Number HFS28PCE

Device Problems Air Leak (1008); Hole In Material (1293); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2014

Event Type  malfunction  

Event Description

During hemodialysis process air was noted in the catheter.After deep evaluation of catheter, small holes have been noticed in the area between access of catheter to patient's skin and triangle/split of blue and red lines.

Manufacturer Narrative

Without an evaluation of the device involved, we are unable to determine the cause or factors that may have contributed to this event.

• Brand Name: 14.5FX28CM PC HEMO-FLOW
• 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: 3912230
• MDR Text Key: 19092456
• Report Number: 2518902-2014-00034
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 05/12/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2016
• Device Model Number: HFS28PCE
• Device Catalogue Number: HFS28PCE
• Device Lot Number: MCWQ240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/14/2014
• Initial Date FDA Received: 05/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2011
• 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