MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC. SPIKE COUPLER; TUBE, TISSUE CULTURE

Model Number	2S-P20
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a cellular transplant a ¿t-connector/spike adapter¿ was being used and while trying to change out the bag of cells, one of the spikes broke off into the cell bag.A new t-connector was used and during cellular infusion takedown the same thing happened where one of the spikes broke off into the bag.

• Brand Name: SPIKE COUPLER
• Common Device Name: TUBE, TISSUE CULTURE
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC.; 7000 burleson rd; building d; austin TX 78744
• MDR Report Key: 18911824
• Report Number: 18911824
• Device Sequence Number: 20539770
• Product Code: KJG
• UDI-Device Identifier: 10816203020021
• UDI-Public: (01)10816203020021
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/17/2024
• Report Date (Section F): 01/17/2024

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: 2S-P20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/15/2024
• 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: 01/17/2024