MAUDE Adverse Event Report: MEDCOMP 12.5FX28CM PC HEMO-CATH; HEMO-CATH LT

Model Number SL28PC-J

Device Problem Leak/Splash (1354)

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

Event Date 10/30/2018

Event Type  malfunction  

Event Description

Before hd (hemodialysis) was started, heparin in the catheter was aspirated with no problem.Blood circuit was connected to the catheter to start hd, and blood removal started.Immediately after this, a large amount of air was confirmed in the blood removal circuit.They checked the catheter and found crack.

Manufacturer Narrative

The device involved in the incident was not returned for investigation.Four (4) photographs were provided.The investigation is based solely on the photographs.There is a hole in the lumen at the junction with the hub.The lot number related to this complaint was not provided therefore a review of the specific manufacture records cannot be performed.As part of the investigation a process review was conducted at final manufacturing level for the operations that could directly cause the reported failure mode.Nothing out of specification was found.The catheter was implanted and used for ten months without any reported problems.The root cause of the issue cannot be determined.

• Brand Name: 12.5FX28CM PC HEMO-CATH
• Type of Device: HEMO-CATH LT
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8219252
• MDR Text Key: 133345723
• Report Number: 2518902-2019-00004
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908046045
• UDI-Public: 884908046045
• 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: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SL28PC-J
• Device Catalogue Number: SL28PC-J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 47