MAUDE Adverse Event Report: MEDCOMP 10FX18CM HEMO-CATH

Model Number	MC101042P
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On aspiration, the line closes completely, and on installation, there is a significant bulge to arterial lumen.
Additional Manufacturer Narrative
The device involved in the incident was not received but two photographs were provided for investigation.The photographs were forwarded to the contract manufacturer for investigation.A record review showed the device was manufactured per specification.The device had been implanted for 1 year and 9 months.The cause of the issue is unlikely to be related to the manufacture process.The most likely cause of this issue is clamping of the extension line in the same location repeatedly over a period of time weakening the extension tubing material.The instructions for use contain the following precaution.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Based on historic data, this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.

• Brand Name: 10FX18CM HEMO-CATH
• Common Device Name: HEMO-CATH
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7885691
• Report Number: 2518902-2018-00048
• Device Sequence Number: 2488848
• Product Code: MSD
• UDI-Device Identifier: 00884908093278
• UDI-Public: 884908093278
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 01/31/2020
• Device Model Number: MC101042P
• Device Catalogue Number: MC101042P
• Device Lot Number: MBZZ760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/20/2018
• Supplement Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/18/2018
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 32