MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 15.5F X 28CM TITAN HD CATHETER; TITAN CATHETER

Model Number THD155028SE.

Device Problem Leak/Splash (1354)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 12/25/2021

Event Type  malfunction  

Manufacturer Narrative

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

The patient complained of bleeding through the catheter during hd session.After examination of the catheter a break was found at the catheter's hub/shaft junction.

Manufacturer Narrative

The device involved in the incident was not returned for evaluation.One photograph was provided confirming the complaint.The contract manufacturer conducted a review of the manufacture records for the lot numbers provided.Their investigation revealed the devices were manufactured and inspected according to specification with no non-conformances or abnormalities.The manufacture process includes a 100% leak test performed as a last step in the process.This test would have detected any holes, leaks, or inferior connection to the hub if the issue existed at the time of manufacture.Without an evaluation of the complained device a root cause cannot be determined.The instructions for use (ifu) were reviewed and include sufficient information, warnings, and precautions regarding the use and care of the device.A review of complaint history for these devices revealed these are the only complaints of this type for this device family.Based on historic data this is not a systemic issue and is considered isolated.This type of event will be trended through the complaint handling process.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.

• Brand Name: 15.5F X 28CM TITAN HD CATHETER
• Type of Device: TITAN 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: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 13142708
• MDR Text Key: 283095994
• Report Number: 2518902-2022-00002
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908053005
• UDI-Public: 884908053005
• Combination Product (y/n): N
• Reporter Country Code: EG
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: THD155028SE.
• Device Catalogue Number: THD155028SE.
• Device Lot Number: MPHK960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• 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): Required Intervention
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 82 KG