MAUDE Adverse Event Report: NON-STERILE SYRINGE; SYRINGE, PISTON

Device Problem Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Description

Our sterile syringes for irrigation that were normally used for tranexamic acid irrigation during a total joint that are administered in the operating room were inadvertently substituted for a non-sterile syringe when ordering.This resulted in using a non-sterile syringe for irrigation in the operating room.An aca is being worked on, but not completed.(b)(6).(b)(4).

• Brand Name: NON-STERILE SYRINGE
• Type of Device: SYRINGE, PISTON
• MDR Report Key: 12835708
• MDR Text Key: 281110749
• Report Number: MW5105453
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/17/2021

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/17/2021
• Patient Sequence Number: 1