MAUDE Adverse Event Report: MEDCOMP 11.5F DUO-FLOW IJ CATHETER; ST HEMODIALYSIS CATHETER

Model Number	XTP114IJSE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation has been initiated by the contract manufacturer.We are waiting for the sample to be returned for evaluation.
Event or Problem Description
Prior to the start of dialysis the dressing was opened and the catheter suture wing was found broken.
Additional Manufacturer Narrative
The supplier opened an internal capa to perform an in-depth investigation.The evaluation of the returned samples and retained samples indicated that the material was exposed to excessive heat.Root cause: temperature fluctuation on the boy molding machine contributed to the reported failure.Corrective action plan: the suture wing will no longer manufactured on the boy molding machine.All manufacturing will be performed on the toyo machine.Preventative action plan: update to the inspection and workmanship standard to provide instructions for additional visual and functional inspection methods.

• Brand Name: 11.5F DUO-FLOW IJ CATHETER
• Common Device Name: ST HEMODIALYSIS CATHETER
• Manufacturer (Section D): MEDCOMP; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 7309472
• Report Number: 2518902-2018-00016
• Device Sequence Number: 13672439
• Product Code: MSD
• UDI-Device Identifier: 00884908058857
• UDI-Public: 884908058857
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2018

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/29/2021
• Device Model Number: XTP114IJSE
• Device Catalogue Number: XTP114IJSE
• Device Lot Number: MCCL210
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2018
• Supplement Date Received by Manufacturer: 02/02/2018
• Initial Report FDA Received Date: 03/02/2018
• Supplement Report FDA Received Date: 07/16/2018
• 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: 44 YR
• Patient Weight: 79