MAUDE Adverse Event Report: ORIGEN BIOMEDICAL 6ML SYRINGE TO SCD TUBE ACCESSORY SET; 6ML SYRINGE, FLL X SCD

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	11/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that a 6ml syringe (part #: rf-t15) was received discolored (yellow) and with loose plungers.The issue was discovered at incoming inspection and did not involve a patient.

• Brand Name: 6ML SYRINGE TO SCD TUBE ACCESSORY SET
• Common Device Name: 6ML SYRINGE, FLL X SCD
• Manufacturer (Section D): 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: 18291823
• Report Number: 1000160256-2023-00001
• Device Sequence Number: 12429265
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/07/2023

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: V23278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2023
• Initial Report FDA Received Date: 12/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown