MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC.; SPLIT CATH II

Model Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Local Reaction (2035); Sepsis (2067); Thromboembolism (2654)

Event Type  malfunction  

Manufacturer Narrative

Information provided shows the medcomp device is the split cath ii.We assume this is a typographical error and the reporter is referring to the split cath iii.Limited information was provided regarding the article.Title, author, and date of publication or the location of the study were not provided making any further investigation on our part impossible.As the article refers to multiple devices from multiple manufacturers resulting in multiple patient reactions but does not indicate which device is involved in which reactions, we are not able to review complaint history.Without further details of the study we are unable to investigate the issue further.

Event Description

According to the literature, a retrospective cohort study between 2012 and 2018 was undertaken to determine the infection free survival rate of tunneled cuffed catheters (tcc), the incidence and causes of catheter failure, and the associated risk factors in children undergoing maintenance hemodialysis through tunneled catheters.Forty-five (45) tccs were inserted in patients between the ages of 5 and 16.Either a silicone mahurkar catheter in sizes 8, 10, or 12.5 fr was used or a competitor device.Nine deaths were reported where 3 died due to catheter related blood stream infection (crbsi) associated sepsis and 6 due to causes unrelated to the catheter.Serious complications included infection in 15 patients where the organism of infection was either gram negative bacilli, klebsiella, pseudomonas, mrsa, citrobacter, acinetobacter, or candida glabra.Infections were treated with either antibiotics or catheter removal.Thrombosis occurred in 13 patients.Thrombosis was treated with either urokinase locking solutions, recombinant-urokinase infusions, or catheter removal.Non-serious complications included 2 kinking and malposition of catheters which were either managed with wire manipulation or catheter removal and 3 catheters that were cracked were removed and replaced with another catheter.The authors do not provide information on which reported adverse events are related to mathurkar catheters or a competitor device.

• Brand Name: UNK
• Type of Device: SPLIT CATH II
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 18426140
• MDR Text Key: 332614066
• Report Number: 2518902-2024-00001
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/28/2023
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention