MAUDE Adverse Event Report: MEDCOMP 14FX24CM SLX; SLX-HEMODIALYSIS CATHETER

Model Number MC061424

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 and the return of the sample for evaluation.

Event Description

2 pin holes in the tubing of the blue port.

Manufacturer Narrative

The contract manufacturer conducted a process review of the device, focusing on the operations that could be directly involved in the cause of the reported failure mode.No non-conformances were noted, all processes were completed to specification.A definitive root cause cannot be determined.

• Brand Name: 14FX24CM SLX
• Type of Device: SLX-HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8179544
• MDR Text Key: 131799352
• Report Number: 2518902-2018-00067
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908083330
• UDI-Public: 884908083330
• Combination Product (y/n): N
• PMA/PMN Number: K893439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 06/28/2019

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: MC061424
• Device Catalogue Number: MC061424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/19/2018
• Supplement Dates Manufacturer Received: 11/21/2018
• Supplement Dates FDA Received: 06/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention