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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD DURASAFE¿ COMBINED ANESTHESIA KIT ANESTHESIA COMBINED SPINAL & EPIDURAL KIT Back to Search Results
Catalog Number 401386
Device Problem Detachment Of Device Component (1104)
Patient Problem No Code Available (3191)
Event Date 07/25/2017
Event Type  Injury  
Manufacturer Narrative
Investigation summary: samples/ photos: samples or photos have not received for analysis of the incident in question. Retain sample evaluation: not apply. Dhr/ qn/ ncmr review: lot 6362812 of the product continuous epidural anesthesia tray, (b)(4) 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, (b)(4), lot: 6081181 used in the claimed tray. Investigation conclusion: not confirmed: bd was unable to confirm or reproduce the complaint. Although the complaint report described a rupture of the epidural catheter used in the anesthesia tray, the incident was not confirmed as being caused by the tray assembly process. The epidural catheter is a component used to mount the anesthesia tray and is purchased from an external supplier (teleflex). In this way, the rupture of the catheter does not originate from the assembly of the tray. In addition, it was found that if the catheter had already ruptured prior to its use, it could not be used during the procedure. Root cause description: based on the investigation, it was not possible to attribute a root cause to the incident in question up to date. Rationale: based on a severity assessment and occurrence it was determined that no capa is required at this time. The complaint was added to the complaint database for trend analysis, which is regularly monitored. Other taken action: even if the incident has not been confirmed, the teleflex provider was informed of the incident in question.
 
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. (b)(4).
 
Event Description
It was reported by a consumer that when inserting a catheter using a bd durasafe¿ combined anesthesia kit, a piece of the guidewire remained in the patient. A scope, resonance, and tomography and neuro surgery were performed. Approximately 6cm of the catheter was removed. The patient was observed and did not present lesions or neural alterations and was discharged from hospital after her/his surgical treatment. The patient was constantly monitored and had no alterations. Patient discharged from hospital and will be monitored by the institution. No further information is available at this time.
 
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Brand NameBD DURASAFE¿ COMBINED ANESTHESIA KIT
Type of DeviceANESTHESIA COMBINED SPINAL & EPIDURAL KIT
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6805729
MDR Text Key246445612
Report Number9610048-2017-00015
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Catalogue Number401386
Device Lot Number6362812
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/18/2017 Patient Sequence Number: 1
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