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

Catalog Number 401387

Device Problem Break (1069)

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

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 during the use of the bd durasafe¿ combined anesthesia kit the catheter broke the tip inside the needle.

Event Description

It was reported that during the use of the bd durasafe¿ combined anesthesia kit the catheter broke the tip inside the needle.

Manufacturer Narrative

Investigation summary: bd was not able to verify the reported issue.Received one used device.The incident was not verified as being caused by the tray mounting process.Epidural catheter is a component used to mount the anesthesia tray and is purchased from an external supplier.In this way, the catheter disruption does not originate from the tray assembly.In addition, according to the client's report the epidural catheter was used the break within the needle was observed after use, it was found that if the catheter had already ruptured prior to its use, it could not be used during the procedure.Dhr review: a review of the device history record was completed for code #401387 lot 7354862 manufactured from 21-dec-17 to 26-dec-17.The batch was analyzed for the damaged product tests and no records of non-compliance or anything that could lead to the incident in question were reported for the claimed lot.In addition, there are no records of non-conformance related to this incident for the epidural catheter component, code: 001818bjf, lot: 7269910 used in the claimed tray.

• Brand Name: BD DURASAFE¿ COMBINED ANESTHESIA KIT
• Type of Device: ANESTHESIA 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: 8160816
• MDR Text Key: 130474939
• Report Number: 9610048-2018-00213
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 401387
• Device Lot Number: 7354862
• Date Manufacturer Received: 11/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other