MAUDE Adverse Event Report: MEDCOMP 15.5F X 32CM TITAN HD CATH; TITAN CATHETER

Model Number THD155432SE.

Device Problem Disconnection (1171)

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

Event Date 03/20/2019

Event Type  malfunction  

Manufacturer Narrative

No device returned and no lot number provided.No further investigation is possible.Without an evaluation of the actual device the root cause of this issue cannot be determined.

Event Description

Catheter was inserted on (b)(6) 2017.On (b)(6) 2019, when attempting to remove the injection cap, the white luer fell off leaving an open connection.Issue was resolved by using a repair kit and shortening the catheter.

• Brand Name: 15.5F X 32CM TITAN HD CATH
• Type of Device: TITAN CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDCOMP; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 8860360
• MDR Text Key: 216680608
• Report Number: 2518902-2019-00048
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908053531
• UDI-Public: 884908053531
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: THD155432SE.
• Device Catalogue Number: THD155432SE.
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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