MAUDE Adverse Event Report: MEDCOMP 14.5FX28CM HEMO-FLOW

Model Number HFS28E.

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Requests have been made for additional information regarding the event and device.

Event Description

Catheter leaking at the lumen to hub junction.

Manufacturer Narrative

The device sample were not returned for evaluation.Attempts to obtain additional information about the device and event and to have the sample returned for evaluation were unsuccessful.Without sufficient information, or an evaluation of the device involved, we are unable to investigate this incident to determine the cause or factors that may have contributed to this event.

• Brand Name: 14.5FX28CM HEMO-FLOW
• Type of Device: HEMO-FLOW
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8240463
• MDR Text Key: 132934643
• Report Number: 2518902-2019-00006
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908017373
• UDI-Public: 884908017373
• 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: 05/15/2019

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 Model Number: HFS28E.
• Device Catalogue Number: HFS28E.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/11/2019
• Supplement Dates Manufacturer Received: 12/13/2018
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention