MAUDE Adverse Event Report: MEDCOMP 15.5FX28CM PC TITAN CATHETER

Model Number	THD155228E.
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: TITAN CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 8064828
• Report Number: 2518902-2018-00059
• Device Sequence Number: 1911953
• Product Code: MSD
• UDI-Device Identifier: 00884908053272
• UDI-Public: 884908053272
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K994105
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 11/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 82 YR
• Patient Weight: 61