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

Model Number 4541

Device Problems Misassembled (1398); Component Missing (2306)

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

Event Date 08/16/2017

Event Type  malfunction  

Event Description

Pudendal syringe (blue attachment) pistol drop was not attached properly to the syringe.This led to the needle moving every-time aspiration was attempted trying to make sure there wasn't an intravascular placement of needle.The top piece of the pistol grip is missing.It was not in the packaging.

Event Description

Pudendal syringe (blue attachment) pistol drop was not attached properly to the syringe.This led to the needle moving every time aspiration was attempted trying to make sure there wasn't an intravascular placement of needle.The top piece of the pistol grip is missing.It was not in the packaging.

• 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: 6882431
• MDR Text Key: 86892678
• Report Number: 6882431
• Device Sequence Number: 1
• Product Code: HEE
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 08/16/2017

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 Model Number: 4541
• Device Catalogue Number: 4541
• 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: 08/16/2017
• Event Location: Hospital
• Date Report to Manufacturer: 08/16/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/29/2017
• 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