MAUDE Adverse Event Report: UNISIS CORP. UNIEVER DISPOSABLE EPIDURAL ANESTHESIA NEEDLE; EPIDURAL NEEDLE

Catalog Number 111113

Device Problem Bent (1059)

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

Event Type  Other  

Event Description

The anesthesiologist informs that the needle is very flexible and brings insecurity in the introduction.

Manufacturer Narrative

We cannot answer to these items as we have not finished our investigation.We will submit the follow-up report as soon as we finish investigation.

• Brand Name: UNIEVER DISPOSABLE EPIDURAL ANESTHESIA NEEDLE
• Type of Device: EPIDURAL NEEDLE
• Manufacturer (Section D): UNISIS CORP.; taito-ku, tokyo ; JA
• Manufacturer (Section G): SAITAMA FACTORY; 2675-1 nishikata; koshigaya-shi, saitama 343- 0822; JA 343-0822
• Manufacturer Contact: 2623-1 nishikata; arakawa-ku; koshigaya-shi, saitama 343-0-822 ; 89908250
• MDR Report Key: 3918320
• MDR Text Key: 4489142
• Report Number: 9681709-2014-00007
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Catalogue Number: 111113
• Device Lot Number: 12E001
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/04/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2012
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1