• 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 ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES INTRAVENOUS 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 ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381137
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2017
Event Type  malfunction  
Manufacturer Narrative
A dhr review was performed. The claimed batch 5173431 of angiocath 20gx1. 88ww was analyzed for the tests that could lead to claimed defect, such as: adhesive transfer test, which is evidence through mark of the sealing film, the adhesiveness of the paper was transferred to the bottom web, assuring the sealing of the product; packaging leakage test, which is a test that challenges the integrity of the sealing, as the holes, sealing channels or any other breach of the sealing that could compromise the sterilization of the product; width and sealing test, which evaluates the parameter according internally specified that the width of the seal should be greater than 3. 2 mm also were all within specifications. All parameters of the sealing machine were within that specified for the claimed lot. Based on this analysis, no records were found that could lead to the incident in question. Conclusion: our quality engineer was unable to verify the reported complaint. There were no records of failure/integrity of the sealing in the batch history analyzes and in the records of no-conformity or quality notification for the claimed lot. In addition, although the sample packs were reported to be open prior to product use, samples or photos of the product are not available for analysis. Without a sample, it has not been possible to reach a conclusion on the root cause of the defect in question. It was determined to implement action change control 084/15 which contemplates the exchange of the supplier of the paper from oliver tolas to arjo which does not have lacquer as adhesive, since the adhesiveness of the paper will be carried out in another way. This action was completed on 11/20/2017. It was determined that no further action is required at this time.
 
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 before use of the bd angiocath¿ iv catheter for special placement procedures the nurse found unit package seal open before use. There was no report of injury or medical intervention.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD ANGIOCATH¿ IV CATHETER FOR SPECIAL PLACEMENT PROCEDURES
Type of DeviceINTRAVENOUS 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 Key7088115
MDR Text Key267646279
Report Number9610048-2017-00076
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/06/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue Number381137
Device Lot Number5173431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/08/2015
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: 12/06/2017 Patient Sequence Number: 1
-
-