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

Catalog Number 401386

Device Problem Break (1069)

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

Event Date 11/01/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd durasafe¿ combined anesthesia kit syringe "shattered" during testing.

Event Description

It was reported that the bd durasafe¿ combined anesthesia kit syringe "shattered" during testing.

Manufacturer Narrative

Investigation summary: since no samples/picture displaying the condition reported are available for examination, we were unable to fully investigate this incident.Neither a complaint history check nor a device history record analysis was performed as the lot number is "unknown" for this complaint.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

• 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: 8096362
• MDR Text Key: 128198192
• Report Number: 9610048-2018-00198
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• 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: 11/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other