MAUDE Adverse Event Report: MEDCOMP 8FX24CM SIL. HEMO-CATH; HEMODIALYSIS CATHETER

Model Number SL24P-J

Device Problem Leak/Splash (1354)

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

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

Received a 8f x 24cm hemo-cath.Leak was reported at the cuff, and complaint was confirmed upon inspection.Device was sent to contract manufacturer for investigation.

Event Description

Wetting on the fixing tape of the catheter had expanded.When the doctor confirmed the route insertion part, he found a pinhole at the boundary between the catheter and the blue hub, and found a leak of infusion.After disinfecting with alcohol cotton, it was protected with "opsite" tape.In order to prevent infection, catheter replacement was performed in the operating room.

Manufacturer Narrative

A visual and functional inspection of the device revealed a hole at the lumen to hub junction that leaked when the device was flushed.The device was forwarded to the contract manufacturer for investigation.We are unable to determine the cause or factors that may have contributed to this event.The device was implanted for 3 months prior to the incident.It appears that the catheter encountered a sharp object resulting in the reported condition.There is no evidence of a manufacturing issue.

• Brand Name: 8FX24CM SIL. HEMO-CATH
• Type of Device: HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8134132
• MDR Text Key: 129378878
• Report Number: 2518902-2018-00065
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908045802
• UDI-Public: 884908045802
• 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: 06/04/2019

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: 03/24/2020
• Device Model Number: SL24P-J
• Device Catalogue Number: SL24P-J
• Device Lot Number: MBXN560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/05/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention