MAUDE Adverse Event Report: MEDCOMP 15.5FX28CM PC TITAN CATHETER

Model Number	THD155228E.
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Death (1802)
Date of Event	06/17/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
An investigation has been initiated.We are currently waiting for the return of the device sample for evaluation.When the investigation is complete a final report will be filed.
Event or Problem Description
Disconnection between the tubing and the catheter.
Additional Manufacturer Narrative
Received a 15.5 titan catheter for evaluation.A visual inspection reveals no damage for defect to the catheter or the luers.The device was forwarded to the device contract manufacturer for evaluation.The investigation of the complaint included a review of the device history record, a review of the returned sample, and the manufacturing process.No rejections or deviations related to the reported failure mode were found during the device history review.There was no visible damaged to the luer.Luer taper was inspected and leak test was performed.Both lumen / luers passed.Root cause could not be determined.No indication the failure was related to the manufacturing process.

• 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: 6941557
• Report Number: 2518902-2017-00055
• Device Sequence Number: 10981134
• 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 Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/02/2021
• Device Model Number: THD155228E.
• Device Catalogue Number: THD155228E.
• Device Lot Number: MCCN070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/25/2017
• Supplement Date Received by Manufacturer: 09/25/2017
• Initial Report FDA Received Date: 10/11/2017
• Supplement Report FDA Received Date: 06/15/2018
• 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: Death
• Patient Age: 88 YR
• Patient Weight: 69