MAUDE Adverse Event Report: MEDCOMP 12.5FX24CM HEMO-CATH; HEMODIALYSIS CATHETER

Model Number MC101243

Device Problem Leak/Splash (1354)

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

Event Date 11/06/2017

Event Type  malfunction  

Manufacturer Narrative

An investigation has been initiated.When the investigation is complete a supplemental report will be submitted.

Event Description

Noticed a leak whilst on dialysis.Cvc kept in situ and other lumen used until fistula matured.

Manufacturer Narrative

The device was forwarded to the contracted manufacturer for review.The contracted manufacturer reviewed the manufacture process for this lot, including the over molding process and 100% leak testing.Based on the investigation performed we are unable to determine the root cause of this issue.

• Brand Name: 12.5FX24CM HEMO-CATH
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7352378
• MDR Text Key: 103168522
• Report Number: 2518902-2018-00023
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908083002
• UDI-Public: 884908083002
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

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: Other
• Device Expiration Date: 01/21/2018
• Device Model Number: MC101243
• Device Catalogue Number: MC101243
• Device Lot Number: MBQV680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/19/2018
• Initial Date FDA Received: 03/20/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 05/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 12 YR