MAUDE Adverse Event Report: CAREFUSION 2200, INC N/A; SET, ANESTHESIA, PARACERVICAL

Model Number	4541
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Pudendal tray syringe broke during procedure.Per physician's report, this is the third syringe that has broken in this fashion that she is aware of recently.When plunger is pressed the piece holding the pistol grip in place broke.Photos attached to this report.

• Brand Name: N/A
• Common Device Name: SET, ANESTHESIA, PARACERVICAL
• Manufacturer (Section D): CAREFUSION 2200, INC; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 7432480
• Report Number: 7432480
• Device Sequence Number: 13501113
• Product Code: HEE
• UDI-Device Identifier: 10885403143250
• UDI-Public: (01)10885403143250
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/30/2018
• Report Date (Section F): 03/30/2018

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: Physician
• Device Expiration Date: 06/07/2021
• Device Model Number: 4541
• Device Catalogue Number: 4541
• Device Lot Number: 0000967173
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/30/2018