MAUDE Adverse Event Report: MERIT MEDICAL CLASSIC SHEATH¿; INTRODUCER, CATHETER

Model Number	10884450163921
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Access needle from sheath kit broke off at the hub in body during dialysis treatment.

• Brand Name: CLASSIC SHEATH¿
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): MERIT MEDICAL; 1600 west merit pkwy.; south jordan UT 84095
• MDR Report Key: 7905070
• Report Number: 7905070
• Device Sequence Number: 1438101
• Product Code: DYB
• UDI-Device Identifier: 10884450163921
• UDI-Public: (01)10884450163921
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/20/2018
• Report Date (Section F): 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10884450163921
• Device Catalogue Number: CLS-1008
• Device Lot Number: Q849837
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 09/25/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/20/2018