MAUDE Adverse Event Report: ORIGEN BIOMEDICAL 6ML SYRINGE TO SCD TUBE ACCESSORY SET

Model Number	RF-T15
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that a 6 ml syringe (part #: rf-t15) was received discolored (yellow).This product was a replacement for previous complained product that had the same issue.

• Brand Name: 6ML SYRINGE TO SCD TUBE ACCESSORY SET
• Common Device Name: 6ML SYRINGE TO SCD TUBE ACCESSORY SET
• Manufacturer (Section D): ORIGEN BIOMEDICAL; 7000 burleson rd; building d; austin TX 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL; 7000 burleson rd; building d; austin TX 78744
• Manufacturer Contact: sam saleh ; 7000 burleson rd; building d; austin, TX 78744 ; 5124747278
• MDR Report Key: 18436256
• Report Number: 1000160256-2023-00002
• Device Sequence Number: 7024283
• Product Code: KJG
• UDI-Device Identifier: 10816203020205
• UDI-Public: 10816203020205
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 12/21/2023

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: Health Professional
• Device Model Number: RF-T15
• Device Lot Number: V23639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-2023-001
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown