MAUDE Adverse Event Report: MEDCOMP 12.5FX28CM PC HEMO-CATH; HEMODIALYSIS CATHETER

Model Number SL28PC-J

Device Problem Air Leak (1008)

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

Event Date 01/13/2013

Event Type  malfunction  

Event Description

Recently they noticed that air bubbles occurred in an extension tube when they worked as a heparin lock to the catheter of one patient.There is no leak, but they replaced the catheter for safety reason.However bubbles still arise and unchanged.

Manufacturer Narrative

Received one 12.5f x 28 cm hemo-cath for evaluation.A visual inspection of the catheter reveals the catheter is in four pieces with the lumen cut into three pieces.The catheter has a 1 cm portion of the lumen still intact, a 4.3 cm piece with the cuff, a 5.4 cm portion with a curve, and a 17.3 cm portion from the curve to the tip.A functional evaluation of the catheter reveals no leakage when the catheter is flushed.A review of the manufacturing records indicated all device specifications and quality requirements were satisfied.We are unable to determine the cause of this event as the reported failure could not be duplicated and no failure was found during the evaluation of the device.

• Brand Name: 12.5FX28CM PC HEMO-CATH
• 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: 4554580
• MDR Text Key: 5522917
• Report Number: 2518902-2015-00017
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SL28PC-J
• Device Catalogue Number: SL28PC-J
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2013
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2013
• 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