MAUDE Adverse Event Report: TELEFLEX INCORPORATED D-STAT; DEVICE, HEMOSTASIS, VASCULAR

Model Number	IPN922573
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Several teleflex d-stat flowable hemostat packages noted to have additional label underneath the packaging label.The label underneath states same device, lot#, and udi; however, expiration date listed as 7-31-2025 vs the new label placed over top as 11-30-2025.

• Brand Name: D-STAT
• Common Device Name: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 24162067
• Report Number: 24162067
• Device Sequence Number: 9001171
• Product Code: MGB
• UDI-Device Identifier: 10841156109080
• UDI-Public: (01)10841156109080
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/24/2025
• Report Date (Section F): 11/24/2025

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
• Device Model Number: IPN922573
• Device Catalogue Number: 4000
• Device Lot Number: 47G2400657
• 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: 01/23/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/23/2026
• 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: 11/24/2025