MAUDE Adverse Event Report: TELEFLEX MEDICAL INC. VASCBAND; CLAMP, VASCULAR

Model Number	IPN914174
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Vasc band hemostat opened to sterile field and tested by inflating with 20ml air.Plastic piece fell off of vasc band.

• Brand Name: VASCBAND
• Common Device Name: CLAMP, VASCULAR
• Manufacturer (Section D): TELEFLEX MEDICAL INC.; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 21630788
• Report Number: 21630788
• Device Sequence Number: 12849668
• Product Code: DXC
• UDI-Device Identifier: 10841156102043
• UDI-Public: (01)10841156102043(17)260824(10)202408922
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/05/2025
• Report Date (Section F): 03/11/2025

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: Other
• Device Model Number: IPN914174
• Device Catalogue Number: 3524
• Device Lot Number: 202408922
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/11/2025