MAUDE Adverse Event Report: TELEFLEX INCORPORATED VASCBAND; CLAMP, VASCULAR

Model Number	IPN914174
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of hypertension and new onset of chest pressure.Having a heart cath, the vasc band was used in the right, radial artery.Balloon would not get firm and the patient kept bleeding.When the juncture of the tubing was moved, it was discovered that the inflatable cuff was kinked at the connection.

• Brand Name: VASCBAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 10835630
• Report Number: 10835630
• Device Sequence Number: 14402558
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: (01)10841156102043(17)220221(10)202002005
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/04/2020
• Report Date (Section F): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN914174
• Device Catalogue Number: 3524
• Device Lot Number: 202002005
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 94
• Date Report Sent to FDA: 11/04/2020