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

Model Number 4541

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

Event Type  malfunction  

Event 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
• Type of Device: SET, ANESTHESIA, PARACERVICAL
• Manufacturer (Section D): CAREFUSION 2200, INC; 400 east foster rd.; mannford OK 74044
• MDR Report Key: 7432480
• MDR Text Key: 105538274
• Report Number: 7432480
• Device Sequence Number: 1
• Product Code: HEE
• UDI-Device Identifier: 10885403143250
• UDI-Public: (01)10885403143250
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1