MAUDE Adverse Event Report: VYGON; EPIDURAL NEEDLE

Device Problems Break (1069); Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2014

Event Type  Other  

Event Description

A doctor (expert in epidural anesthesia) felt unusual resistance during puncture, so he decided to stop the puncture.At this moment, the needle was complete, but after removing, the needle broke in his hands.The needle was twisted.No health occurred to the patient.

Manufacturer Narrative

We will submit the f/u report as soon as we finish investigation.

• Brand Name: NA
• Type of Device: EPIDURAL NEEDLE
• Manufacturer (Section D): VYGON; FR
• Manufacturer (Section G): SAITAMA FACTORY; 2675-1 nishikata, koshigaya-shi; saitama 343- 0822; JA 343-0822
• Manufacturer Contact: 2623-1 nishikata, koshigaya-shi; saitama 343-0-822 ; 89908250
• MDR Report Key: 3772789
• MDR Text Key: 4357105
• Report Number: 9681709-2014-00003
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2014

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2014
• Initial Date FDA Received: 03/06/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 55