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

Catalog Number 401386

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

(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 foreign matter occurred with a bd durasafe¿ combined anesthesia kit.The following information was provided by the initial reporter, "material for epidural access puncture contained a 20 ml syringe with signs of contamination.It had gelatinous transparent material inside.".

Event Description

It was reported that foreign matter occurred with a bd durasafe¿ combined anesthesia kit.The following information was provided by the initial reporter, "material for epidural access puncture contained a 20ml syringe with signs of contamination.It had gelatinous transparent material inside.".

Manufacturer Narrative

H.6.Investigation: dhr was performed and no qn or maintenance records that could be related to the incident were observed.The available samples and photos were analyzed and it was not possible to observe the reported incident.A root cause could not be determined because the complaint is unconfirmed.

• 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: 8671224
• MDR Text Key: 147520959
• Report Number: 9610048-2019-00199
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 07891463001016
• UDI-Public: 7891463001016
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 401386
• Device Lot Number: 8242853
• Date Manufacturer Received: 05/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other