MAUDE Adverse Event Report: FERROSAN MEDICAL DEVICES A/S SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN; AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED

Model Number	2994
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
When scrub person tried to mix the surgiflo none of the fluid went into the vial.The fluid ran out from under the transfer cap and down the sides of the bottle.

• Brand Name: SURGIFLO® HEMOSTATIC MATRIX KIT WITH THROMBIN
• Common Device Name: AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED
• Manufacturer (Section D): FERROSAN MEDICAL DEVICES A/S; 1000 route 202; raritan NJ 08869
• MDR Report Key: 17208384
• Report Number: 17208384
• Device Sequence Number: 14837843
• Product Code: LMF
• UDI-Device Identifier: 15712123000288
• UDI-Public: (01)15712123000288(17)231231(10)269516
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2023
• Report Date (Section F): 04/25/2023

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: 2994
• Device Lot Number: 269516
• 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: 06/27/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2023
• 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: Female
• Patient Weight: 59 KG
• Date Report Sent to FDA: 04/25/2023