MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD DURASAFE¿ COMBINED ANESTHESIA KIT; ANETHESIA COMBINED SPINAL & EPIDURAL KIT

Catalog Number 401386

Device Problem Material Integrity Problem (2978)

Patient Problem Needle Stick/Puncture (2462)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that there was an accidental puncture while using the bd durasafe¿ combined anesthesia kit.The following information was provided by the initial reporter: accidental puncture of the dura mater - 3 occurrences in one week.The anesthesiology team is accustomed to using the braun epidural kit - as it is an ultra fine sensitivity, the epidural puncture, the change of the mark implies a great modification of the sensitivity in expiration of the plans the anesthesiology team released exceeded by the needle.

Event Description

It was reported that there was an accidental puncture while using the bd durasafe¿ combined anesthesia kit.The following information was provided by the initial reporter: accidental puncture of the dura mater - 3 occurrences in one week.The anesthesiology team is accustomed to using the braun epidural kit - as it is an ultra fine sensitivity, the epidural puncture, the change of the mark implies a great modification of the sensitivity in expiration of the plans the anesthesiology team released exceeded by the needle.

Manufacturer Narrative

Investigation: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Bd was not able to duplicate or confirm the customer¿s indicated failure as no sample, batch, or lot code was provided.A dhr could not be performed as the lot# is unknown.

• Brand Name: BD DURASAFE¿ COMBINED ANESTHESIA KIT
• Type of Device: ANETHESIA COMBINED SPINAL & EPIDURAL KIT
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8620311
• MDR Text Key: 145401481
• Report Number: 9610048-2019-00181
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 401386
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other