• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD SAF-T E-Z SET¿ INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD SAF-T E-Z SET¿ INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 387346
Device Problem Hole In Material (1293)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/11/2017
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter last name: (b)(6). Fax reporter phone #: (b)(6). Results. Investigation summary: one open and one used sample of saft-ez-set 21g product, catalog: 387346, lot: 7088924 was received for analysis. According to visual analysis of the sample it can be verified that there was a hole in the product tube that may have caused the bubbles in the tube during the collection of blood. Dhr review: the following assembled wing lot used in the claimed final product lot 7088924 was analyzed. Lot #7053949, was analyzed for tests of "damaged component" and no records of this defect were detected for the batch analyzed. Unplanned maintenance: a corrective maintenance history was evaluated in the period of final assembly of product and the corrective maintenances on machines were evidenced with reason: "tube nipped. ¿ according to investigations performed these maintenances may lead to reported occurrence in this complaint. Investigation conclusion: confirmed: bd was able to confirm the incident in question. Investigation comments: besides the analysis of the sample returned from the customer, there was evidence of a hole on the tube, the analysis of the corrective maintenance history showed "tube nipped" during the manufacture of lot 7053949. This is enough to confirm this complaint. 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.
 
Event Description
It was reported there was a hole in the tubing found on a bd saf-t e-z set¿ during use. There was no report of injury or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD SAF-T E-Z SET¿
Type of DeviceINTRAVASCULAR CATHETER
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 Key7162247
MDR Text Key96479434
Report Number9610048-2017-00099
Device Sequence Number1
Product Code FOZ
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 foreign,health professional,o
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Catalogue Number387346
Device Lot Number7088924
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/10/2017
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: 01/03/2018 Patient Sequence Number: 1
-
-