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

Model Number HFS28PCE.

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 12/24/2016

Event Type  malfunction  

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.The investigation could not determine the root cause for the failure.Excessive manipulation of the device, method of preparation, handling and/or cleaning of the product may compromise cuff adherence to the tissue.

Event Description

Cuff completely exposed outside exit site.

• Brand Name: 14.5FX28CM PC HEMO-FLOW
• 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 Key: 6312354
• MDR Text Key: 67227557
• Report Number: 2518902-2017-00003
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908017427
• UDI-Public: 884908017427
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2017

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: Health Professional
• Device Model Number: HFS28PCE.
• Device Catalogue Number: HFS28PCE.
• Device Lot Number: MHRX170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 65