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

Model Number RF-T15

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2023

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 331803398
• Report Number: 1000160256-2023-00002
• Device Sequence Number: 1
• Product Code: KJG
• UDI-Device Identifier: 10816203020205
• UDI-Public: 10816203020205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: RF-T15
• Device Lot Number: V23639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-2023-001
• Patient Sequence Number: 1
• Patient Outcome(s): Other