MAUDE Adverse Event Report: MEDCOMP 15.5FX28CM PC TITAN CATHETER

Model Number THD155228E.

Device Problem Disconnection (1171)

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

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

The device involved in the incident remains implanted in the patient and in use.No evaluation can be performed.The device was implanted for 63 days prior to the incident.Without an evaluation of the device the investigation cannot determine if the failure was related to the manufacturing process.It is unlikely due to the device having been in use and continues to be used with no reported problems.It is possible the connection was not fully secured.Included in the instructions for use are the following.Precaution: to prevent accidents, assure the security of all caps and bloodline connections prior to and between treatments.Warning: in the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.

Event Description

Nurse checks the connection of the catheter and noticed some blood on the surgical drape as the venous connection with the blood line was partially unscrewed.Device was not removed.No clinical consequences.

• Brand Name: 15.5FX28CM PC TITAN CATHETER
• 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: 8064828
• MDR Text Key: 128324119
• Report Number: 2518902-2018-00059
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00884908053272
• UDI-Public: 884908053272
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K994105
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2021
• Device Model Number: THD155228E.
• Device Catalogue Number: THD155228E.
• Device Lot Number: MCAY760
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2018
• Initial Date FDA Received: 11/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 61