MAUDE Adverse Event Report: CADENCE SCIENCE, INC. MICRO-MATE; PRESSURE CONTROL SYRINGE

Model Number	5340
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation will be completed upon receipt of the syringes from the user.At such time we will follow-up and update the mdr with final actions and determinations.
Event or Problem Description
The glass syringe broke at the top flange where the pressure control rings attach to the glass.The customer reported that while in surgery, scrub tech drew up lidocaine and handed the glass syringe to the surgeon.The surgeon injected the patient and when pressure was applied to administer the medication, where the rings attach to the vial "popped" apart.No patients have been harmed.The syringe itself doesn't break/shatter - the ring that has the 2 loops breaks away from the syringe.

• Brand Name: MICRO-MATE
• Common Device Name: PRESSURE CONTROL SYRINGE
• Manufacturer (Section D): CADENCE SCIENCE, INC.; 2080 plainfield pike; cranston RI 02921
• MDR Report Key: 8457996
• Report Number: 0001213649-2019-00001
• Device Sequence Number: 14217247
• Product Code: FMF
• UDI-Device Identifier: 00816329023404
• UDI-Public: 816329023404
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/27/2019

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 Expiration Date: 01/31/2023
• Device Model Number: 5340
• Device Catalogue Number: 5340
• Device Lot Number: W051186/1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1