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U.S. Department of Health and Human Services

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

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NON-STERILE SYRINGE SYRINGE, PISTON Back to Search Results
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).
 
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Brand NameNON-STERILE SYRINGE
Type of DeviceSYRINGE, PISTON
MDR Report Key12835708
MDR Text Key281110749
Report NumberMW5105453
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided

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