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

Model Number SL28PC-J

Device Problem Air Leak (1008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/15/2016

Event Type  malfunction  

Manufacturer Narrative

Received one 12.5f x 28cm hemo-cath for evaluation.A visual inspection reveals the catheter to be in 2 pieces.There is a small tear/cut in the lumen right below the hub.A review of the manufacturing records indicated that all device specifications and quality requirements were satisfied.This family of devices is 100% leak tested during the manufacturing process and inspection.There is no evidence of swelling, crumbling, discoloration, degradation or polymer variation of the lumen material.The catheter was inserted and used for 2.5 years prior to the failure.There is no evidence of a manufacturing defect.We are unable to determine the cause or factors that may have contributed to this event.It appears that the catheter may have come into contact with a sharp object.

Event Description

Home care noticed blood on gauze.Visit to the (b)(6) hospital for dialysis the next day (b)(6) 2016 again bleeding was observed, confirming the mixing of air in a- side line prior to dialysis.Dialysis stopped - bleeding was in the hub vicinity.

• Brand Name: 12.5FX28CM PC HEMO-CATH
• 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: beth giammaruti ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 5547776
• MDR Text Key: 42555962
• Report Number: 2518902-2016-00006
• 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: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2016
• 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
• Other Device ID Number: 8804908046045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/02/2016
• 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