MAUDE Adverse Event Report: MEDCOMP 15.5FX28CM PC TITAN CATHETER

Model Number THD155228E.

Device Problem Disconnection (1171)

Patient Problem Death (1802)

Event Date 06/17/2017

Event Type  Death  

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 Description

Disconnection between the tubing and the catheter.

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
• 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: 6941557
• MDR Text Key: 89029673
• Report Number: 2518902-2017-00055
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/11/2017
• Supplement Dates Manufacturer Received: 09/25/2017
• Supplement Dates FDA Received: 06/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2016
• 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): Death
• Patient Age: 88 YR
• Patient Weight: 69