MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12F TESIO CATH /CUFF SET; HEMODIALYSIS CATHETER

Model Number MCTC1235SD

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Shock (2072)

Event Date 08/09/2023

Event Type  Death  

Manufacturer Narrative

An investigation has been initiated.Currently waiting for additional information.The hospital started an internal investigation (sire) and the catheter needs to stay in the hospital until the investigation is done.Afterwards the distributor may possibly be able pick up the part that got disconnected and return it for evaluation.Because the patient died the catheter portion that was inserted needed to remain in the patient.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Patient had the dialysis catheter since (b)(6) this year.Last wednesday august 9th the patient went for dialysis and was connected to the machine for 3h50m.10 minutes before the end the catheter sort of ruptured.It disconnected above the tego connector.The patient started bleeding and went into shock and needed cpr.Unluckily the patient did not survive this event.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.The internal portion of the device remained with the patient due to the death.A picture of the external portion of the catheter was provided.This portion of the device is being kept by the facility for their internal investigation.The picture showed the white luer with a yellow tego connector attached, and a small segment of the lumen.One edge of the lumen segment has a straight edge, and the other end was cut at an angle.The information provided indicated "the angled end of the remaining part of the catheter lumen in the picture was attached inside the luer".The lumen did not tear but came loose (pulled free) from the luer.There was no lumen left inside the luer.Without the lot number a review of the manufacturing records was not possible.Without an evaluation of the device that was involved a root cause determination was not possible.It is possible that the luer was incorrectly assembled onto the lumen and during the treatment pulled free from the luer.During product design verification/validation force at break testing was performed for this device.All samples tested met the acceptance criteria for force at break for every joint in accordance with en iso 10555-1:2013+a1:2017 and the relevant medcomp procedures.

Manufacturer Narrative

Update: the luer, end cap, and approximately 2+ cm of lumen were released from the facility following completion of their investigation and returned for evaluation.The complaint has been reopened for further investigation.Engineering conducted testing of the returned repair luer adaptor with (10) lumens- (5) non-sterile lumen samples and (5) sterile lumen samples.The initial testing was conducted using the repair luer that was returned from the field and non-sterile lumens pulled from inventory.The returned repair luer was assembled to the lumen.The results of the tensile test show that when the luer and lumen are assembled the juncture exceeded the iso 10555-1 requirements as well as historical data for the same components found in the design verification/validation testing.All samples passed.Iso acceptance criteria is 3.37lbf (15n).The average force at break value in this testing is 6.28lbf.Testing was also conducted using the repair luer that was returned from the field and sterilized lumens.The returned repair luer was assembled to the lumen after 1x sterilization.The results of the tensile test show that when the luer and lumen are fully assembled the juncture exceeded the iso 10555-1 requirements and aligned with the historical data for the same components found in the design verification/validation testing.All samples passed.The average force at break value in this testing is 6.07lbf.Testing was also performed where the parts were assembled incorrectly, similar to how the returned luer/lumen was observed.The average force at break value in this testing is 3.06lbf.This value is below acceptance criteria.The lower force values were expected as the lumen was not fully engaged on the luer which resulted in the lower force values.A definitive root cause could not be determined; however, it is possible the device was not correctly assembled which contributed to the failure.There is no evidence of a manufacturing issue.

• Brand Name: 12F TESIO CATH /CUFF SET
• Type of Device: HEMODIALYSIS CATHETER
• 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: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 17555770
• MDR Text Key: 321230061
• Report Number: 2518902-2023-00054
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908027242
• UDI-Public: 00884908027242
• Combination Product (y/n): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MCTC1235SD
• Device Catalogue Number: MCTC1235SD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death